2BSNV-EAPW01EASEE Power

Precisis GmbH, Margot-Becke-Ring 8, D-69124 Heidelberg PRECISIS GmbH Registered Office: Heidelberg, Registration Court Mannheim, HRB 741686, VAT-ID: DE 198388707 Managing Directors: Karl Stoklosa, Michael Tittelbach Margot-Becke-Ring 8 69124 Heidelberg, Germany Tel.: +49 6221 6559300 Fax: +49 6221 6559310 [email protected] www.precisis.de 02.12.2025 U.S. Agent Designation Precisis GmbH acknowledges their consent for the following contact located in the United States to act as their agent for service of process for the equipment for which authorization is sought (FCC ID: 2BSNV-EAPW01): Name of contact person (U.S. agent)*: Perry Rice Company of U.S. agent (if applicable): Precisis US Physical U.S. address of agent* (PO box is not acceptable): 724 Bielenberg Drive, PMB #6, Woodbury, MN 55125 FRN of U.S. agent*: 0037674504 Email address of U.S. agent*: [email protected] Phone number of U.S. agent*: +1 (651) 492-8261 Perry Rice acknowledges their obligation to accept service of process on behalf of Precisis GmbH. Precisis GmbH with the FRN 0037566866 accepts its obligation to maintain an agent for service of process in the United States for no less than one year after either the grantee has permanently terminated all marketing and importation of the applicable equipment within the U.S., or the conclusion of any Commission-related administrative or judicial proceeding involving the equipment, whichever is later. By signing this form, we confirm the above and that we are aware of the application requirements listed under § 2.911(d)(7). The information provided in this letter is based on the referenced rule parts of Title 47 of the CFR as well as KDB 986446 D01. An expiration date for this letter does not exist. In case the U.S. agent changes, the grantee is obligated to notify the FCC within 30 days via the granting TCB. By signing this agreement, the U.S. agent agrees to respond to inquiries from Eurofins Product Services GmbH (TCB) or the FCC in order to verify accuracy of the information provided within 7 days of receipt. Sincerely, Signature* Christian Wessinger Senior Supply Chain Manager Precisis GmbH Signature* Perry Rice VP, US Clinical Operations Precisis US Federal Communications Commission Authorization and Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 48_[mo del] US_Agent_2.911(d)(7) - U, V06

Precisis GmbH, Margot-Becke-Ring 8, D-69124 Heidelberg PRECISIS GmbH Registered Office: Heidelberg, Registration Court Mannheim, HRB 741686, VAT-ID: DE 198388707 Managing Directors: Karl Stoklosa, Michael Tittelbach Margot-Becke-Ring 8 69124 Heidelberg, Germany Tel.: +49 6221 6559300 Fax: +49 6221 6559310 [email protected] www.precisis.de Federal Communications Commission Authorization and Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 12/2/2025 To whom it may concern: We, Precisis GmbH, hereby certify that the equipment for which authorization is sought (FCC ID: 2BSNV- EAPW01) is not “covered” equipment prohibited from receiving an equipment authorization pursuant to § 2.903 of the FCC rules. We also certify that, as of the date of the filing of the application, we are not identified on the Covered List (https://www.fcc.gov/supplychain/coveredlist) as an entity producing “covered” equipment. We also certify that, as of the date of the filing of the application, the equipment does not utilize cyber- security or anti-virus software from Kapersky Lab, Inc, or any of its successors and assignees, which is also on the “covered list” By signing this form, we confirm the above and that we are aware of the application requirements listed under § 2.911(b) and (d)(5) and (6). The information provided in this letter is based on the referenced rule parts of Title 47 of the CFR as well as KDB 986446 D01. Sincerely, ___________________________ Christian Wessinger Senior Supply Chain Manager Precisis GmbH 62_[model] CoveredEq u_2.911(d)(5)(i) and (ii) - U, V0 4

Precisis GmbH, Margot-Becke-Ring 8, D-69124 Heidelberg PRECISIS GmbH Registered Office: Heidelberg, Registration Court Mannheim, HRB 741686, VAT-ID: DE 198388707 Managing Directors: Karl Stoklosa, Michael Tittelbach Margot-Becke-Ring 8 69124 Heidelberg, Germany Tel.: +49 6221 6559300 Fax: +49 6221 6559310 [email protected] www.precisis.de 1/1 02.12.2025 To whom it may concern: We, the undersigned, hereby authorize Eurofins Product Service GmbH to act on our behalf in all matters relating to applications for equipment authorization FCC ID: 2BSNV-EAPW01 including the signing of all documents related to these matters. Any and all acts carried out by Eurofins Product Service GmbH on our behalf shall have the same effect as acts of our own. By signing this form, we agree to Eurofins’ current valid General Terms and Conditions (AGB),Testing and Certification Regulations (PZO) which can be viewed on following website www.eurofins.de/ee or retrieved on request. We also hereby certify that no party to this application is subject to a denial of benefits, including FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Sincerely, Signature Christian Wessinger Senior Supply Chain Manager Precisis GmbH Federal Communications Commission Authorization and Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046

Precisis GmbH, Margot-Becke-Ring 8, D-69124 Heidelberg PRECISIS GmbH Registered Office: Heidelberg, Registration Court Mannheim, HRB 741686, VAT-ID: DE 198388707 Managing Directors: Karl Stoklosa, Michael Tittelbach Margot-Becke-Ring 8 69124 Heidelberg, Germany Tel.: +49 6221 6559300 Fax: +49 6221 6559310 [email protected] www.precisis.de Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 Heidelberg, December 16, 2025 Re: Precisis GmbH Request For Confidentiality Precisis EASEE® Power - FCC ID 2BSNV-EAPW01 - FCC Part 95 Certification To whom it may concern, Precisis GmbH requests that the information contained in the items enumerated below pertaining to the above-referenced application be withheld from public disclosure in accordance with Section 0.459 of the Commission’s Rules, 47 C.F.R. § 0.457, following grant of the application. In support of this request, Precisis GmbH submits the following: 1. identification of the specific information for which confidential treatment is sought: a. identification of exhibits for long-term confidential treatment • Schematics • Parts List • Block Diagram • Internal Photographs • Operational Description The materials set forth in these exhibits, which are segregated from the nonconfidential exhibits of the application, are those for which permanent confidentiality is sought. b. identification of Exhibits for Short-Term Confidentiality (180 days) • External Photographs • Test Setup Photographs • User Manual The materials set forth in these exhibits, which are segregated from the nonconfidential exhibits of the application, are those for which short-term confidentiality is sought. 2. identification of the Commission proceeding in which the information was submitted or a description of the circumstances giving rise to the submission: The proceeding is that involving the application for and certification request for FCC ID 2BSNV-EAPW01. 3. explanation of the degree to which the information is commercial or financial, or contains a trade secret or is privileged: PRECISIS GmbH Registered Office: Heidelberg, Registration Court Mannheim, HRB 741686, VAT-ID: DE 198388707 Managing Directors: Karl Stoklosa, Michael Tittelbach Margot-Becke-Ring 8 69124 Heidelberg, Germany Tel.: +49 6221 6559300 Fax: +49 6221 6559310 [email protected] www.precisis.de 2/3 This information is embodied in circuit diagrams, detailed explanations, parts lists, a block diagram and internal photographs of a completely sealed device designed for implantation in a human body. As such, this material is treated as highly confidential business information and information that could convey trade secrets pertaining to manufacturing and design techniques. 4. explanation of the degree to which the information concerns a service that is subject to competition: The information for which confidentiality is sought is employed in the design and manufacture of medical implantable devices that are offered on a highly competitive basis. Customers for this equipment have a variety of competing sources of supply from both domestic and foreign suppliers. 5. explanation of how disclosure of the information could result in substantial competitive harm: Disclosure would, in effect, give away the fruits of the labors of Precisis’s engineering personnel, who have designed the equipment and the manufacturing processes. Disclosure would also offer competitors additional unwarranted insight into the state of product development thereby allowing such competitors an advantage that would not be available to Precisis. 6. identification of any measures taken by the submitting party to prevent unauthorized disclosure: The information for which confidential treatment is sought is kept confidential by Precisis and not made available to third parties except pursuant to arrangements designed to prevent public disclosure. The circuit board or internal components are not accessible to users. They are enclosed in a titanium housing hermetically sealed by welding. The header is embedded in epoxy. The device cannot be opened without using brute force and destroying the device. The device is intended to be surgically implanted in the human body and is not accessible to the public. 7. identification of whether the information is available to the public and the extent of any previous disclosure of the information to third parties: To the knowledge of those preparing this application, the information has not been disclosed publicly heretofore. The protection sought is narrowly drawn and pertains to certain specific implementations of the technology incorporated into the device for which certification is sought. 8. justification of the period during which the submitting party asserts that material should not be available for public disclosure: While improvements in design are likely to be made during this period, disclosure of the design information would lead to insights into both designs and manufacturing techniques and could have an adverse competitive effect for many years to come. This application contains information that will be used in future applications for similar devices. Moreover, the radio communication aspects of this device are employed in the programming of a medical implant device and in the transmission of highly private medical information to and from the device. Disclosure of the information for which confidentiality is sought could jeopardize the protection of such personal private medical information generated for the benefit of patients into whom the PRECISIS GmbH Registered Office: Heidelberg, Registration Court Mannheim, HRB 741686, VAT-ID: DE 198388707 Managing Directors: Karl Stoklosa, Michael Tittelbach Margot-Becke-Ring 8 69124 Heidelberg, Germany Tel.: +49 6221 6559300 Fax: +49 6221 6559310 [email protected] www.precisis.de 3/3 device has been implanted. As such, it is important that information pertaining to the design and operation of this device no…

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© 2025 Precisis GmbH Version 2.0 / 11 November 2025 EASEE® Power; Torque Wrench Page 1 of 8 Device Information about EASEE® Power and Torque Wrench For Investigational Use Only Version 2.0 11 November 2025 For more detailed information, please refer to the Instructions for Use (Neurosurgeon’s Manual, Neurologist’s Manual, Patient’s Manual) Images EASEE® Power Torque Wrench Reference number EASEE System Basic UDI-DI: 426047977022426 EASEE® Power: EAPW01 Torque Wrench: not applicable (sub-component of EASEE® Power) © 2025 Precisis GmbH Version 2.0 / 11 November 2025 EASEE® Power; Torque Wrench Page 2 of 8 Description EASEE® Power is an implantable pulse generator of electrical pulses. It consists of a housing which holds batteries for electrical power supply and the stimulation control electronics. It further comprises a header that contains an RF antenna to communicate with external devices and a connector block with a set screw for connecting EASEE® Lead, another component of the EASEE® System, used for transmitting and delivering the electrical pulses. EASEE® Power is to be used in combination with EASEE® Lead. The Torque Wrench is a torque limited screwdriver for EASEE® Power. It is used to tighten or loosen the above- mentioned set screw to mechanically fix EASEE® Lead to EASEE® Power. EASEE® Power as well as the Torque Wrench are provided sterile and are sterilized using ethylene oxide. DO NOT RESTERILIZE. Prior to use of EASEE® Power or the Torque Wrench, inspect the sterile packages for seal integrity. If the packaging appears to be wet, punctured, or damaged, the contents may no longer be sterile, and these components should be returned to Precisis GmbH for replacement. Legal Manufacturer Precisis GmbH Postal Address: Phone: tbd Margot-Becke-Ring 8 Fax: +49-6221-655 9310 69124 Heidelberg E-Mail: [email protected] GERMANY Website: www.precisis.de/en Single registration number (SRN) DE-MF-000016826 Intended Use The EASEE® System, which includes EASEE® Power and a torque wrench, is indicated for use as an adjunctive therapy for reducing the burden of epilepsy in adults with focal onset seizures that are refractory to two or more antiepileptic medications. Classification Directive 90/385/EEC: “Active Implantable Medical Device" Regulation 2017/745, Annex VIII: “Class III Medical Devices” GMDN Code: 62653 (Epicranial Brain Electrical Stimulation System) UMDNS Code: 17-758 (Stimulators, Cranial Electrotherapy) EIEC 62304: Class B (Firmware of EASEE® Power) © 2025 Precisis GmbH Version 2.0 / 11 November 2025 EASEE® Power; Torque Wrench Page 3 of 8 Symbols used on markings and labels Only the symbols affixed on marking and labels do apply for the specific device of the EASEE System. The following table provides an overview of all symbols used on the individual components of the EASEE System for information purposes. Symbol Description General warning sign Refer to instructions for use (obligatory) Manufacturer Date of manufacture (YYYY-MM-DD) Use by date (YYYY-MM-DD) MR (magnetic resonance) imaging conditional Do not re-use Do not resterilize Do not use if package is damaged Type BF applied part IP XY Degree of enclosure protection (IP Code) against ingress of solid bodies (x) or liquids (y) Non-ionizing electromagnetic radiation Sterilized using ethylene oxide Package content Medical Device Reference number Lot number Serial number Unique Device Identification (example only) GS1 datamatrix code UDI © 2025 Precisis GmbH Version 2.0 / 11 November 2025 EASEE® Power; Torque Wrench Page 4 of 8 Symbol Description Refer to instructions for use (advisable) Keep away from sunlight Keep dry Temperature limit Atmospheric pressure limitation Humidity limitation Affixed in accordance with MDR (EU) 2017/745. Hereby, Precisis GmbH declares that this device is in compliance with the essential requirements and other relevant provisions of these Regulations. Specifications EASEE ® Power WIDTH 50.50 mm (2 in) LENGTH 60.00 mm (2.4 in) THICKNESS 12.95 mm (0.5 in) WEIGHT 66 g (2.3 oz) MATERIAL Can Titanium, medical grade 2 Top part Epoxy resin Nozzle Silicone Fixing screw septum Silicone BATTERY Number 2 System LiMnO2 Voltage 3.2 V Type Primary Nominal capacity per battery 1.2 Ah STORAGE CONDITIONS Temperature 10 °C to 25 °C 50°F to 77°F Atmospheric pressure 700 hPa to 1060 hPa Relative humidity ≤ 85 %; non-condensing © 2025 Precisis GmbH Version 2.0 / 11 November 2025 EASEE® Power; Torque Wrench Page 5 of 8 TRANSPORT CONDITIONS Temperature -10 °C to 55 °C 14°F to 131°F Atmospheric pressure 700 hPa to 1060 hPa Relative humidity ≤ 85 %; non-condensing OPERATING CONDITIONS Temperature 18 °C to (39 °C typically; 42 °C short-term) 64.4 °F to (102.2 °F typically; 107.6 °F short term) Atmospheric pressure 700 hPa to 1060 hPa Relative humidity 30 %...65 %; non-condensing (if not implanted) NUMBER OF OUTPUT CHANNELS 4 RETENTION STRENGTH OF CONNECTOR 10 N WAVE FORM Biphasic PULSE SHAPE Rectangular CURRENT/VOLTAGE REGULATION Current regulated MAX. OUTPUT CURRENT 4.0 mA ± 0.1 mA HFS STIMULATION PARAMETERS Amplitude 0.1 mA...4.0 mA Current amplitude step width 0.1 mA Pulse width per phase 100 μs ... 1500 μs Frequency 100 Hz; 160 Hz Repetition frequency 0.5/min; 1/min; 2/min; 4/min; 6/min. Burst duration 40 ms ... 500 ms Bursts per day 659...8640 PCN PARAMETERS Amplitude 0.1 mA...4.0 mA Current amplitude step width 0.1 mA Pulse width per phase 100 μs ... 1500 μs Frequency 100 Hz; 160 Hz PCN burst duration 10 s ... 60 s Step width of PCN burst duration 5 s Number of PCN bursts Maximum of one burst per two minutes. Maximum of 6 mins total duration per day DLS STIMULATION PARAMETERS Stimulation pulse amplitude 0.2 mA...4.0 mA Current amplitude step width 0.1 mA Stimulation pulse to equalization pulse amplitude ratio 5:1 Stimulation pulse width 20 ms Stimulation pulse to equalization pulse width ratio 1:5 Frequency 8 Hz Burst duration 2 min. ... 20 min. © 2025 Precisis GmbH Version 2.0 / 11 November 2025 EASEE® Pow…

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Precisis GmbH, Margot-Becke-Ring 8, D-69124 Heidelberg PRECISIS GmbH Registered Office: Heidelberg, Registration Court Mannheim, HRB 741686, VAT-ID: DE 198388707 Managing Directors: Karl Stoklosa, Michael Tittelbach Margot-Becke-Ring 8 69124 Heidelberg, Germany Tel.: +49 6221 6559300 Fax: +49 6221 6559310 [email protected] www.precisis.de Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 2025-12-02 Re: Precisis GmbH Request For Exemption from Compliance Statement on Package for Medical Implant – Precisis EASEE Power FCC ID 2BSNV-EAPW01 FCC Part 95 Certification Precisis GmbH requests that the information contained in the FCC rules enumerated below pertaining to the above-referenced application provide exemption from compliance statement on the package on our Medical Implantable device – Precisis EASEE Power FCC ID 2BSNV-EAPW01: Pursuant to 1. section 47 CFR 95.2593 (a) MedRadio labeling requirements: MedRadio transmitters must be labeled in accordance with the requirements in this section. (a) MedRadio programmer/control transmitters operating in the 401-406 MHz band shall be labeled as provided in part 2 of this chapter and shall bear the following statement in a conspicuous location on the device: “This device may not interfere with stations operating in the 400.150-406.000 MHz band in the Meteorological Aids, Meteorological Satellite, and Earth Exploration Satellite Services and must accept any interference received, including interference that may cause undesired operation.” 2. And 47 CFR 95.2593(d) (d) If it is not feasible to place the statement specified by paragraph (a), (b), or (c) of this section on the device, it may be placed in the instruction manual for the transmitter instead. PRECISIS Aktiengesellschaft Sitz Heidelberg, Registergericht Mannheim, HRB 338089, USt-IdNr.: DE 198388707 Vorstand: Dr. Angela Liedler, Vorsitzender des Aufsichtsrates: Berth Hausmann Hauptstr. 73 69117 Heidelberg, Germany Tel.: +49 6221 6559300 Fax: +49 6221 6559310 [email protected] www.precisis.de 2/2 Since our Precisis EASEE Power FCC ID2BSNV-EAPW01 is a medical implantable device with a small package label size, the FCC compliance statements per 47 CFR 95.2593 (a) and 47 CFR 95.2595(a) are not feasible on the implant package label, and following alternative labeling methods are implemented: • Both compliance statements required per 47 CFR 95.2593 (a) and 47 CFR 95.2595 (a) are included in the User’s Manual: DO08-124_EASEE Power Device information_US_v02.00 Respectfully submitted, Signature Christian Wessinger Senior Supply Chain Manager Precisis GmbH

Precisis GmbH, Margot-Becke-Ring 8, D-69124 Heidelberg PRECISIS GmbH Registered Office: Heidelberg, Registration Court Mannheim, HRB 741686, VAT-ID: DE 198388707 Managing Directors: Karl Stoklosa, Michael Tittelbach Margot-Becke-Ring 8 69124 Heidelberg, Germany Tel.: +49 6221 6559300 Fax: +49 6221 6559310 [email protected] www.precisis.de Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 2025-12-02 Re: Precisis GmbH Request For Exemption from FCC ID labeling on Medical Implant – Precisis EASEE Power FCC ID No.: 2BSNV-EAPW01 FCC Part 95 Certification Ladies and Gentlemen, Precisis GmbH requests that the information contained in the item enumerated below pertaining to the above-referenced application provide exemption from FCC Identifier labeling on our Medical Implantable device: Precisis EASEE Power FCC ID 2BSNV-EAPW01 Pursuant to section 47 CFR 2.925(f): “(f) The FCC Identifier including the term “FCC ID” shall be in a size of type large enough to be readily legible, consistent with the dimensions of the equipment and its label. However, the type size for the FCC Identifier is not required to be larger than eight-point. If a device is so small that it is impractical to label it with the FCC Identifier in a font that is four-point or larger, and the device does not have a display that can show electronic labeling, then the FCC Identifier shall be placed in the user manual and must also either be placed on the device packaging or on a removable label attached to the device.” Note to paragraph (f): As an example, a device intended to be implanted within the body of a test animal or person would probably require an alternate method of identification.” PRECISIS Aktiengesellschaft Sitz Heidelberg, Registergericht Mannheim, HRB 338089, USt-IdNr.: DE 198388707 Vorstand: Dr. Angela Liedler, Vorsitzender des Aufsichtsrates: Berth Hausmann Hauptstr. 73 69117 Heidelberg, Germany Tel.: +49 6221 6559300 Fax: +49 6221 6559310 [email protected] www.precisis.de 2/2 Since our Precisis EASEE Power FCC ID 2BSNV-EAPW01 is a medical implantable device, the FCC ID on the implant is not feasible and following alternative methods are implemented: • The FCC ID 2BSNV-EAPW01 and the compliance statements required are in the User’s Manual: DO08-124_EASEE Power Device information_US_v02.00. • The FCC ID 2BSNV-EAPW01 appears on the package label and affixed to the shipping box. Respectfully submitted, Signature Christian Wessinger Senior Supply Chain Manager Precisis GmbH

[-EAPW01] EASEE® Power EAPW01 ID Label Location Complete Label (3 separate parts) Sales packaging label (part 1) FCC ID Blister packaging label (part 2) FCC ID Sales packaging side label (pt. 3) FCC ID 2BSNV-EAPW01 FCC ID 2BSNV-EAPW01

[-EAPW01] EASEE® Power (REF EAPW01) ID Label Location Sales Box with Label (Part 1): FCC ID Sterile Blister Packaging: Blister Outer Tray Lid with Label Part 2: Label part 2 FCC ID

Precisis GmbH, Margot-Becke-Ring 8, D-69124 Heidelberg PRECISIS GmbH Registered Office: Heidelberg, Registration Court Mannheim, HRB 741686, VAT-ID: DE 198388707 Managing Directors: Karl Stoklosa, Michael Tittelbach Margot-Becke-Ring 8 69124 Heidelberg, Germany Tel.: +49 6221 6559300 Fax: +49 6221 6559310 [email protected] www.precisis.de Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 2025-12-02 Re: Precisis GmbH Request For Exemption from SAR Testing Requirements for Medical Implant – Precisis EASEE Power FCC ID 2BSNV-EAPW01 FCC Part 95 Certification To whom it may concern, Precisis GmbH requests that the information contained in the item enumerated below pertaining to the above-referenced application provide exemption from SAR measurement or numerical simulation for our Medical Implantable device – Precisis EASEE Power FCC ID 2BSNV-EAPW01: FCC KDB 447498 General RF Exposure Guidance D01 v05r02, Section 4.2.4, the FCC provides a power threshold, below which transmitters implanted in the body of a user are excluded from SAR measurement or numerical simulation: "4.2.4 Transmitters implanted in the body of a user When the aggregate of the maximum power available at the antenna port and radiating structures of an implanted transmitter, under all operating circumstances, is ≤ 1.0 mW, SAR test exclusion may be applied. The maximum available output power requirement and worst- case operating conditions must be supported by power measurement results and fully justified in a SAR analysis report, in lieu of the SAR measurement or numerical simulation, according to design and implementation requirements of the device." Since both the maximum conducted and radiated output power are well below 1.0 mW, this Medical Implantable device – Precisis EASEE Power FCC ID 2BSNV-EAPW01 is therefore excluded from SAR measurement or numerical simulation. FCC ID: 2BSNV-EAPW01 is compliant with FCC RF Exposure requirements. Respectfully submitted, Christian Wessinger Senior Supply Chain Manager Precisis GmbH

Test Report No.: G0M-2509-3285-TFC95IMR01-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 1 of 54 RADIO REPORT FCC 47 CFR Part 95I Medical Device Radiocommunication Service (MedRadio) Report Reference No G0M-2509-3285-TFC95IMR01-V01 Testing Laboratory Eurofins Product Service GmbH Address Storkower Str. 38c 15526 Reichenwalde Germany Accreditation DAkkS - Registration number : D-PL-12092-01-00 FCC Filed Test Laboratory, Reg.-No.: 96970 Applicant Precisis GmbH Address Margot-Becke-Ring 8 69124 Heidelberg GERMANY Test Specification 47 CFR Part 95I Non-Standard Test Method None Equipment under Test (EUT): Product Description EASEE Power: AIMD (Active Implantable Medical Device) Model(s) EASEE Power (Implant, REF EAPW01) Brand Name(s) EASEE Hardware Version(s) EASEE Power: E1.35 Software Version(s) EASEE Power: v2.8.5 FCC ID 2BSNV-EAPW01 Test Result PASSED Test Report No.: G0M-2509-3285-TFC95IMR01-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 2 of 54 Possible test case verdicts: Required by standard but not tested N/T Not required by standard N/R Not applicable to EUT N/A Test object does meet the requirement P(PASS) Test object does not meet the requirement F(FAIL) Testing: Test Lab Temperature 20 °C - 30 °C Test Lab Humidity 25 % - 55 % Date of receipt of test item See test sample identification table on page 6 Report: Compiled by Md Abu Bakar Siddique Tested by (+ signature) (Responsible for Test) Md Abu Bakar Siddique ....................................................... Approved by (+ signature) (Senior Radio Expert) Florian Voigt ....................................................... Date of Issue 2025-12-10 Total number of pages 54 General Remarks: 1. The test results presented in this report relate only to the object tested, as it was provided by the customer, and under the test conditions described in this report. The results contained in this report reflect the results for this particular model and serial number. It is the responsibility of the manufacturer to ensure that all production models meet the intent of the requirements detailed within this report. 2. The relevant information are provided by customers in this test report. According to the correctness, appropriateness or completeness of the information provided by the customer, if there is any doubt or error in the information which affects the validity of the test results, the laboratory does not take the responsibility. 3. The issuing testing laboratory tested the equipment mentioned on first page in accordance with the requirements set forth in the test specifications mentioned on first page. All indications of Pass/Fail in this report are opinions expressed by Eurofins Product Service GmbH based on interpretations and/or observations of test results. When the test result on first page shows the status “PASSED”, the equipment tested is capable of demonstrating compliance with requirements as documented in this test report. 4. This report shall not be reproduced, except in full, without the written approval of the issuing testing laboratory. Additional Comments: None Test Report No.: G0M-2509-3285-TFC95IMR01-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 3 of 54 VERSION HISTORY Version History Version Issue Date Remarks Revised By 01 2025-12-10 Initial Release -- 02 YYYY-MM-DD Replaced document xxx Replaced by xxx Reason/Changes xxx Test Report No.: G0M-2509-3285-TFC95IMR01-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 4 of 54 ABBREVIATIONS AND ACRONYMS Acronyms Acronym Description EUT Equipment Under Test FCC Federal Communications Commission ISED Innovation, Science and Economic Development Canada RBW Resolution bandwidth RMS Root mean square VBW Video bandwidth V NOM Nominal supply voltage Test Report No.: G0M-2509-3285-TFC95IMR01-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 5 of 54 REPORT INDEX 1 Equipment (Test Item) Under Test................................................................................................... 6 1.1 Support Equipment ........................................................................................................................................ 7 1.2 EUT Configuration ......................................................................................................................................... 8 1.3 Test mode duty cycle .................................................................................................................................... 9 1.4 Test Modes ................................................................................................................................................. 13 1.5 Test Frequencies ..........................................................................…

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