2AYSJFL-100Flow tDCS Device

Document Doc.Id. Version Name of document GR 21-005 01 Issued by (Name/Signature) Date Isac Salman 2021-02-17 Approved by (Name/Signature) Date Erik Rehn 2021-02-17 RECORD HISTORY VER CHANGE ISSUED BY DATE 1 First issue (edited copy of GR 17-015 Core text for IFU- Flow FL-100 ver12) Isac Salman 2021-02-17 Template Doc.id. Version Core Text Template FL 09-04-01 TMP 03 Approval Table Document Doc.Id. Version Name of document GR 21-005 01 1 PROJECT MANAGERYES NO NA 1.1 Coherence to specifications & technical documentation ✓ 1.2 Procedures are safe, effective, accurate & complete ✓ 1.3 Illustrations are technically accurate ✓ 1.4 Warnings & cautions included where necessary ✓ 1.5 Project Manager Signature Approved 2 MARKETING & SALES YES NO NA 2.1 Document & language is accurate (Proofread) ✓ 2.2 Material is professional ✓ 2.3 Agrees with experience of intended user ✓ 2.4 Marketing and Sales Manager Signature Approved 3 QUALITY YES NO NA 3.1 Correct symbols are used ✓ 3.2 Hazardous situations are highlighted with adequate symbols & warnings ✓ 3.3 MDD and ISO 13485 requirements are met ✓ 3.4 Requested changes (CR) are implemented ✓ 3.5 Document ID is correct ✓ 3.6 Document is within Intended Use ✓ 3.7 All claims are correct according to regulatory approvals ✓ 3.8 Quality Manager Signature Approved 4 SUPPLYYES NO NA 4.1 Item numbers, terminology and pricing will be applicable ✓ 4.2 The product (IFU) will work in production ✓ 4.3 Supply Manager Signature Approved Template Doc.Id. Version Core Text Template FL 09-04-01 TMP 03 Document Doc.Id. Version Name of document GR 21-005 01 START OF THE CORE TEXT USER MANUAL Model: ​FL-100 Page: 03 English Get started by downloading the app ​“Flow - Depression”​. Template Doc.Id. Version Core Text Template FL 09-04-01 TMP 03 Document Doc.Id. Version Name of document GR 21-005 01 Table of Contents 1. Manufacturer5 2. Intended Use5 3. Box Contents & the Headset5 4. Accessories6 5. Precautions6 6. Warnings7 7. Possible Adverse Reactions7 8. Prerequisites8 9. The Treatment Programme8 10. First-Time Use8 11. How to Perform a Treatment Session9 12. Charging the Headset10 13. Cleaning of the Headset10 14. FCC10 15. Compliance Notice11 14. Device Specifications12 15. Markings13 16. Product Disposal14 17. Contact Us14 18. EMC - Test Results14 Template Doc.Id. Version Core Text Template FL 09-04-01 TMP 03 Document Doc.Id. Version Name of document GR 21-005 01 Instruction for Use – Flow - Instructions on how to use the Flow headset and the accompanying smartphone app. - IFU Version and Issuing date: ​Ver 2020-08-21 - Product model: ​FL-100​. - The latest version of this manual is also available to download from flowneuroscience.com. 1. Manufacturer Flow Neuroscience AB Baltzarsgatan 23; 211 36 Malmö; Skåne län, Sweden 2. Intended Use - Flow is a class IIa Medical Device intended for home-based treatment of adults (18+) diagnosed with Major Depressive Disorder (MDD). - Flow does not require any special training before use. 3. Box Contents & the Headset 1. Instructions for Use 2. Micro-USB Charger & Cord 3. Two Pad Holder Rings 4. Flow Headset 5. Button 6. LED indicator 7. Electrodes 8. Metal arch 9. Back piece 10. Pads 11. Charger port cover After each use, put the headset and other parts back in the box. Template Doc.Id. Version Core Text Template FL 09-04-01 TMP 03 Document Doc.Id. Version Name of document GR 21-005 01 4. Accessories More Pads can be ordered online at ​flowneuroscience.com​. Reuse​ of pads may cause skin damage. Always start a stimulation sess ion with a new pair of Headset pads. 5. Precautions Using this device poses minimal risk of injury. Even so, it is recommended to consider multiple treatment options. If​symptoms worsen​, make sure to contact a​healthcare professional. The Flow device should only be used by people over ​18 years of age who have been diagnosed with depression (Major Depressive Disorder). Always ​consult a physician​ before making any changes to your current ​medication. Take extra precaution and make sure to consult your physician under the following circumstances: - Pregnancy (or suspected pregnancy) - Suicidal thoughts (thoughts about ending your life) - Bipolar disorder (or having a history of hypomanic/manic episodes) - Epilepsy (or having a history of seizures) - Heart disease (or suspected heart disease) - A neurological or neuropsychiatric condition - Having recently had a surgical procedure - Having a defect in neurocranium and/or an implant inside the skull ACCESSORIES ITEMS DEFINITION HEADSET PADS A BOX OF HEADSET PADS CONTAINING 20 POUCHES (SINGLE USE) MICRO USB CHARGER A LXCP12-005 CHARGER AND CORD Template Doc.Id. Version Core Text Template FL 09-04-01 TMP 03 Document Doc.Id. Version Name of document GR 21-005 01 - Having an active, implanted medical device (e.g. cardiac pacemaker, spinal cord stimulator, vagal nerve stimulator, auricular stimulator, deep- brain stimulating electrodes, cochlear implant, implanted hearing aid or defibrillator) or other implanted metallic or electronic device. 6. Warnings - Apply the headset ONLY on the head as directed and not on other body parts. - Keep the headset dry and out of sunlight. - Keep the headset out of the reach of children. - Do not apply the headset over areas of skin that lack normal sensations. - Do not apply the headset outdoors or close to water. - Do not apply the headset while driving. - Do not apply the headset during any activity creating a significant risk of injury. - Do not apply the headset while intoxicated or incapacitated. - Do not apply the headset in environments with strong magnetic fields. - Do not apply the headset without the supplied Headset Pads. - Do not apply the headset with dried-out Headset Pads (Pads are single use). - Do not charge the headset with any other charger than the one supplied with the headset. -Worsening of ​symptoms:​If you experience a significant ​worsening of your symp t oms while using this device, consult a ​physician b…

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Flow Neuroscience AB ADD: Baltzarsgatan 23, 211 36 Malmo, Sweden TEL: +46736607170 FAX: N/A E-mail: [email protected] Date: 2021-3-1 FEDERAL COMMUNICATIONS COMMISSION Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 Dear Sir/Madam, We, Flow Neuroscience AB, hereby authorize Bay Area Compliance Laboratories Corp. to act as a laboratory for testing and test report generation for the following project(s): (Product name: Flow tDCS device, Model name: FL-100, FCC ID:2AYSJFL-100) The chip N52832 supports BT and BLE mode, but for this device, only BLE 1M was active, the other was disable by software. Sincerely Yours, Client’s signature Printed Name: Erik Rehn Title: CTO

QA-FR-171-A Flow Neuroscience AB ADD: Baltzarsgatan 23, 211 36 Malmo, Sweden TEL: +46736607170 FAX: N/A E-mail: [email protected] FCC Confidential Authorization Date: 2021-3-1 FEDERAL COMMUNICATIONS COMMISSIONS Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 Subject: Confidentiality Request regarding application for certification of FCC ID:2AYSJFL-100 In accordance with Sections 0.457 and 0.459 of the Commission’s Rules, (Flow Neuroscience AB) hereby requests long-term confidential treatment of information accompanying this application as outlined below:  Block Diagram  Schematics  Operation Description The above materials contain proprietary and confidential information not customarily released to the public. The public disclosure of these materials provides unjustified benefits to its competitors in the market. Sincerely, Signature: Printed Name: Erik Rehn Title: CTO

EXHIBIT B - EUT EXTERNAL PHOTOGRAPHS

Download the app in the App Store. Search for Flow - Depression. Create an account or login. Click on the three lines. Click Profile. Click Certifications. E-label will appear.

EXHIBIT C - EUT INTERNAL PHOTOGRAPHS Antenna

FCC PART 15.247 TEST REPORT For Flow Neuroscience AB Baltzarsgatan 23, 211 36 Malmö, Sweden Report Type: Original Report Product Name: Flow tDCS device Re port Number: RDG210128001-00A Re port Date: 2021-04-07 Reviewed By: Ivan Cao Assistant Manager Test Laboratory: Bay Area Compliance Laboratories Corp. (Dongguan) No.12, Pulong East 1 st Road, Tangxia Town, Dongguan, Guangdong, China Tel: +86-769-86858888 Fax: +86-769-86858891 www.baclcorp.com.cn FCC ID: 2AYSJFL-100 Bay Area Compliance Laboratories Corp. (Dongguan) Report No.: RDG210128001-00A Page 2 of 29 TABLE OF CONTENTS GENERAL INFORMATION ....................................................................................................................................... 4 PRODUCT DESCRIPTION FOR EQUIPMENT UNDER TEST (EUT) ..................................................................................... 4 OBJECTIVE ................................................................................................................................................................... 4 TEST METHODOLOGY .................................................................................................................................................. 4 MEASUREMENT UNCERTAINTY .................................................................................................................................... 5 TEST FACILITY ............................................................................................................................................................. 5 DECLARATIONS ............................................................................................................................................................ 5 SYSTEM TEST CONFIGURATION .......................................................................................................................... 6 DESCRIPTION OF TEST CONFIGURATION ...................................................................................................................... 6 EQUIPMENT MODIFICATIONS ....................................................................................................................................... 6 EUT EXERCISE SOFTWARE .......................................................................................................................................... 6 EQUIPMENT MODIFICATIONS ....................................................................................................................................... 7 BLOCK DIAGRAM OF TEST SETUP ................................................................................................................................ 8 SUMMARY OF TEST RESULTS ............................................................................................................................... 9 FCC §15.247 (i) & §1.1310 & §2.1093- RF Exposure ............................................................................................... 10 APPLICABLE STANDARD ............................................................................................................................................ 10 FCC §15.203 - ANTENNA REQUIREMENT ........................................................................................................... 11 APPLICABLE STANDARD ............................................................................................................................................ 11 ANTENNA INFORMATION AND CONNECTOR CONSTRUCTION ..................................................................................... 11 FCC §15.209, §15.205, §15.247(d) - SPURIOUS EMISSIONS ................................................................................. 12 APPLICABLE STANDARD ............................................................................................................................................ 12 EUT SETUP ................................................................................................................................................................ 12 EMI TEST RECEIVER & SPECTRUM ANALYZER SETUP .............................................................................................. 13 TEST PROCEDURE ...................................................................................................................................................... 13 CORRECTED AMPLITUDE & MARGIN CALCULATION ................................................................................................. 13 TEST EQUIPMENT LIST AND DETAILS ......................................................................................................................... 14 TEST DATA ................................................................................................................................................................ 14 FCC §15.247(a) (2) –6 dB EMISSION BANDWIDTH ............................................................................................. 20 APPLICABLE STANDARD ............................................................................................................................................ 20 TEST PROCEDURE ...................................................................................................................................................... 20 TEST EQUIPMENT LIST AND DETAILS ......................................................................................................................... 20 TEST DATA ................................................................................................................................................................ 21 FCC §15.247(b) (3) - MAXIMUM PEAK CONDUCTED OUTPUT POWER ...................................................... 23 APPLICABLE STANDARD ............................................................................................................................................ 23 TEST PROCEDURE ...................................................…

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EXHIBIT D - TEST SETUP PHOTOGRAPHS Radiated Emission Below 1GHz View Radiated Emission Above 1GHz View