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2ASE7-BIOST05020BioButton V2

BioIntelliSense, Inc.
BioButton V2 - FCC ID 2ASE7-BIOST05020 - BioIntelliSense, Inc.
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Application Details

Equipment Class
DTS - Digital Transmission System
Date of Grant
Dec 23, 2020
Application Purpose
Original Equipment
Date of Application
Dec 23, 2020
Equipment Note
BioButton V2
Frequency Range
2402.00000000 - 2480.00000000
Company
BioIntelliSense, Inc.
Country
United States

Documents & Files

Select a file to view

Users Manual

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Cover Letter(s)

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External Photos

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ID Label/Location Info

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Internal Photos

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RF Exposure Info

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Test Report

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Test Setup Photos

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Document Text

Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.

Users Manual

135 24 You’re done! GET STARTED Press and hold the BioButton™ button for 2 SECONDS. Proceed when the LIGHT blinks repeatedly. Find adhesive. Peel the backing from DEVICE SIDE of adhesive. INTRODUCTION Instructions for Use Locate area on UPPER LEFT CHEST, two inches below collar bone. TRIM ANY BODY HAIR using only an electric trimmer and CLEANSE AREA with a warm, damp cloth. Adhere BioButton to chest. Apply pressure for 15 SECONDS. Place the BioButton ON the exposed adhesive. Turn over and remove remaining adhesive backing. For additional support, please call 888.908.8804 or email [email protected] NO RAZORS NOWAXING NOALCOHOL 70%         N PRESS & HOLD LIGHT R e m o v e A d h e s i v e B a c k i n g For complete instructions, visit: BioIntelliSense.com/support INTENDED USE The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data. The device is intended for use on users who are 18 years of age or older. The device does not output heart rate or respiratory rate measurements during periods of motion or activity. The device is not intended for use on critical care patients. NOTICE: Use of the BioIntelliSense Product(s) is subject to our Website and Product User Terms of Use at (BioIntelliSense.com/website-and-product- user-terms-of-use), Website Privacy Policy at (BioIntelliSense.com/website-privacy-policy), and Product and Data-as-a-Service Privacy Policy at (BioIntelliSense.com/product-and- service-privacy-policy). By using the Product(s), you indicate you have read these terms and policies and that you agree to them, including the limitations and disclaimers of liability. In particular, you understand and consent that use of the Product(s) measures and records personal information about you, including vital sign and other physiologic measurements. That information may include respiratory rate, heart rate, temperature, activity level, sleep duration, body position, step count, gait analysis, coughing, sneezing and vomit frequency and other symptomatic or biometric data. The Product(s) may also be configured to track and record proximity and duration data in relation to other Product(s). You understand that the Product(s) do not render medical advice or diagnose or prevent any specific disease, including any communicable disease or virus. If you have any concerns about your health, including whether you have been exposed to or have contracted any disease or virus, immediately contact your healthcare provider. In the event of a medical emergency, dial 911 immediately. 6 Proprietary & Confidential - Page 1 of 3 - Uncontrolled if Printed • Remove the BioButton prior to any defibrillation events. Clinical validation has not been performed for persons who have a defibrillator or pacemaker device. • Keep the device away from children and pets. The BioButton device may be a choking hazard and may be harmful if swallowed. • Press the BioButton’s button regularly to verify that it is working. • DO NOT wear device over excessive body hair. Excessive body hair should be trimmed using only an electric trimmer, before application. • DO NOT place on broken skin including wounds, sores, or abrasions. • DO NOT submerge the device in more than 3 feet of water or submerge for longer than 30 minutes at a time. Prolonged exposure to water may cause the device to loosen from the skin. • DO NOT continue wearing if severe discomfort or irritation occurs. • DO NOT exert excessive force, drop, modify, or attempt to take apart the device. Doing so may cause malfunction or permanent damage. • DO NOT wear or use the BioButton during a magnetic resonance imaging (MRI) procedure or in a location where it will be exposed to strong electromagnetic forces. Can I shower or exercise with the BioButton? Yes, the BioButton is water resistant and can be worn during showers and exercise. Do not apply any deodorant or lotion to the placement areas as it will reduce adhesion of the device to the skin. Can I swim or bathe with the BioButton? Yes, the BioButton is water resistant and will continue working as long as it is not submerged more than 3 feet or kept underwater for longer than 30 minutes at a time. Prolonged exposure to water may cause the device to loosen from the skin. I’m experiencing some skin irritation, what should I do? Minor skin irritation and itching may occur while wearing the BioButton. If a severe reaction develops (i.e. hives or blisters), discontinue wearing and immediately contact your physician. How long should I wear my device? Please wear your device for the entire monitoring period, but no longer than 90 days. Each adhesive may be worn for up to 7 continuous days. You may replace the adhesive more often, as needed, to ensure good contact is maintained with the skin. How do I know my device is working? Press and release BioButton’s button. The device light will blink 4 times. If the device does not blink or blinks more than 4 times, please immediately contact Customer Support. I’ve tried activating the device several times, and the light still won’t blink. What do I do? Contact Customer Support immediately (see front cover). You may be instructed to return the device and may receive a replacement kit if more data is needed for the monitoring period. • When no longer sticky. • If you experience minor irritation or redness in placement area. REPLACE YOUR ADHESIVE REMOVE adhesive from bottom of device. Follow steps 4 thru 6 to put on a new adhesive and reapply BioButton. fifi WARNINGS & PRECAUTIONS TROUBLESHOOTING & FAQS When replacing the adhesive, it is advised to apply the device in a different location within the placement area. SEPTEMBER 2020 BBN-LBL-DWG-IFU Rev.0 PRESS LIGHT Press the BioButton’s button and confirm the light blinks 4 TIMES. If the device blinks more than 4 times or does not blink at all, please contact support. VERIFY DE…

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Cover Letter(s)

RF_160, Issue 04 BioIntelliSense, Inc. Declaration of Authorization W e Name: BioIntelliSense, Inc. Address: 570 El Camino Real #200 City: Redwood City Country: United States D eclare that: N ame Representative of agent: Daphne Liang (1) Agent Company name: SGS Compliance Certification Services Inc. Address: No.8,Jiucengling,Xinhua Dist., City: Tainan City. Country Taiwan R.O.C i s authorized to apply for Certification of the following product(s): P roduct description: BioButton V2 Type designation: BIOST05020F Trademark: BIOBUTTON Validity/ expiry date 2021-12-15 on our behalf. D ate: 2020-12-15 Ci ty: Redwood City, CA ,USA Name: Tracy Cheng Func tion: .........Head of Manufacturing...................... S ignature: ............................... Notes: (1): Required for FCC application (2): For FCC it must be the Grantee Code “owner” or the authorized agent.

Cover Letter(s)

FCC, Request for non-disclosure Date: 21-Nov-2018 RF_501, Issue 8 Page 1 of 1 Company Name: BioIntelliSense, Inc. Address: 570 El Camino Real #200 City: Redwood City Country: United States To: Telefication B.V., Dept. FCC TCB Edisonstraat 12A 6902 PK ZEVENAAR The Netherlands Subject: Request for confidentiality FCC ID: 2ASE7-BIOST05020 Reference number: ###### Dear FCC TCB, 1. Long-Term Confidentiality Pursuant to 47 CFR Section 0.459(a) & (b), we hereby requests non-disclosure and confidential treatment of the following materials submitted in support of FCC c ertification application: Bill(s) of Material Block Diagrams Operational Description Schematic Diagrams Tune-up Procedure Above materials contain secrets, p roprietary and technical information, which would customarily be guarded from competitors under 47 CFR, section 0.457(d)(2). Disclosure or publication or any portion of this company confidential material to other parties could cause substantial competitive harm and provide unjustified benefits for competitors. 2. Short-Term Confidentiality (STC) Pursuant to Public Notice DA 04-1705 of the Commission’s policy, in order to comply with the marketing regulations in 47 CFR §2.803 and the importation rules in 47 CFR §2.1204, a pplicant hereby requests Short-Term Confidential treatment of the following materials (See notes below): Internal Photos User’s Manual Test Set-up Photos External Photos Justification: To keep our new product development confidential. STC : 45 days Date: 2020-12-15 Name and signature of applicant: Notes: 1) A document or type of document can only have ONE type of confidentiality! 2) Short-Term confidentiality is in principle for 45 days from date of grant; it can be extended max 3 times (total time 180 days max.)! The planned date should stated in the RF731 application form. 3) FCC must be informed when marketing begins earlier. 4) Release takes place automatically thus extension must be requested in time. Telefication does not remind you of this! 5) Request for extension or for release must be received by Telefication at least 7 days before date of actual marketing or before expiration of the STC period

Cover Letter(s)

Antenna Describe 1. Antenna describe 2. External view drawing Picture: Antenna Dimensions Antenna plate Monopole antenna Make name/model name MD1827/1831 Antenna gain 0dBi Frequency range 2.4GHz-2.483GHz Connector type direct Location of company name ShengHai Electronics(shenzhen)Ltd Table: Antenna Dimensions L1 3.94mm L2 2.70mm L3 5.00mm L4 2.64mm L5 2.00mm L6 4.90mm W1 0.90mm W2 0.50mm D1 0.50mm D2 1.40mm D3 1.70mm

External Photos

Page 1 / 5 Report No.: T201209N02 Ref. No.: Rev. 00 External Photo (Model: BIOST05020F)

ID Label/Location Info

3 15.3mm 10.07mm 4.6mm 4mm 8mm 3.6mm 4mm 7mm 7mm 15.3mm 24.13mm 13.53mm 9.8mm16.8mm 11.59mm

Internal Photos

Page 2 / 5 Report No.: T201209N02 Ref. No.: Rev. 00 Internal Photo (Model: BIOST05020F) Page 3 / 5 Report No.: T201209N02 Ref. No.: Rev. 00 Page 4 / 5 Report No.: T201209N02 Ref. No.: Rev. 00 Page 5 / 5 Report No.: T201209N02 Ref. No.: Rev. 00

RF Exposure Info

Page: 1 / 1 Report No.: T201209N02-MF Rev.: 00 No.8, Jiucengling, Xinhua Dist., Tainan City, Taiwan /8 t:(886-6) 5802-201 f:(886-6) 5802-202 www.sgs.com.tw www.ccsrf.com Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at http://www.sgs.com.tw/Terms-and-Conditions and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at http://www.sgs.com.tw/Terms-and-Conditions. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of client’s instruction, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced, except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. Compliance Certification Services Inc. Member of the SGS Group Declaration of SAR Exclusion Letter According to KDB 447498 section 4.3.1, the 1-g SAR test exclusion thresholds at test separation distance ≤ 50 mm are determined by: [(max. power of channel, including tune-up tolerance, mW) / (min. test separation distance, mm)] *·[f(GHz)] ≤ 3.0 The tune-up power is 0 dBm +/- 0.5dBm, therefore the highest tune-up power is 0.50 dBm (1.12 mW) @ 2402 MHz When the minimum test separation distance is < 5 mm, a distance of 5 mm according to 5) in section 4.1 is applied to determine SAR test exclusion. So, ( (1.12 mW) / 5mm ) * ( 2.402GHz ^0.5 )= 0.3 [(max. power of channel, including tune-up tolerance, mW) / (min. test separation distance, mm)] * [f(GHz)] = 0.3 < 3.0 Therefore, standalone SAR measurements are not required for both head and body. Approved b y: Eric Huang Section Manager

Test Report

FCC ID: 2ASE7-BIOST05020 Page: 1 / 60 Report No.: T201209N02-RP1 Rev.: 00 No.8, Jiucengling, Xinhua Dist., Tainan City, Taiwan /台南市新化區礁坑里九層嶺8號 t:(886-6) 5802-201 f:(886-6) 5802-202 www.sgs.com.tw www.ccsrf.com Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. 除非另有說明,此報告結果僅對測試之樣品負責,同時此樣品僅保留90天。本報告未經本公司書面許可,不可部份複製。 This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at http://www.sgs.com.tw/Terms-and-Conditions and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at http://www.sgs.com.tw/Terms-and-Conditions. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of client’s instruction, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced, except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. Compliance Certification Services Inc. 程智科技股份有限公司 Member of the SGS Group FCC 47 CFR PART 15 SUBPART C AND ANSI C63.10: 2013 TEST REPORT For BioButton V2 Model: BIOST05020F Issued for BioIntelliSense Inc. 570 El Camino Real #200, Redwood City, CA 94063, USA Issued by Compliance Certification Services Inc. Tainan Lab. No.8, Jiucengling, Xinhua Dist., Tainan City, Taiwan Issued Date: December 21, 2020 Note: This report shall not be reproduced except in full, without the written approval of Compliance Certification Services Inc. Ltd. This document may be altered or revised by Compliance Certification Services Inc. personnel only, and shall be noted in the revision section of the document Page: 2 / 60 Report No.: T201209N02-RP1 Ref. No.: Rev.: 00 REVISION HISTORY Rev. Issue Date Revisions Effect Page Revised By 00 December 21, 2020 Initial Issue ALL Gina Lin 01 February 25, 2020 See the following note rev.01 ALL Gina Lin 02 February 26, 2020 See the following note rev.02 Page10 Gina Lin Note: ※ Rev.00 Issue Date: February 13, 2020 Original Report ※ Rev.01 Issue Date: February 25, 2020 Revise typo & Measurement Equipment & Average Power & Test Procedure. ※ Rev.02 Issue Date: February 26, 2020 Revise Measurement Equipment. Page: 3 / 60 Report No.: T201209N02-RP1 Ref. No.: Rev.: 00 TABLE OF CONTENTS 1. TEST REPORT CERTIFICATION ............................................................................... 4 2. TEST RESULT SUMMARY ......................................................................................... 5 3. EUT DESCRIPTION ..................................................................................................... 6 3.1 DESCRIPTION OF EUT & POWER ...................................................................................... 6 4. DESCRIPTION OF TEST MODES ............................................................................... 7 5. TEST METHODOLOGY ............................................................................................... 8 6. FACILITIES AND ACCREDITATIONS ........................................................................ 8 6.1 FACILITIES ............................................................................................................................ 8 6.2 EQUIPMENT .......................................................................................................................... 8 6.3 LABORATORY ACCREDITATIONS LISTINGS .................................................................... 8 6.4 TABLE OF ACCREDITATIONS AND LISTINGS ................................................................... 9 7. CALIBRATION AND UNCERTAINTY ....................................................................... 10 7.1 MEASURING INSTRUMENT CALIBRATION ...................................................................... 11 7.2 MEASUREMENT UNCERTAINTY ....................................................................................... 11 8. SETUP OF EQUIPMENT UNDER TEST ................................................................... 12 8.1 SETUP CONFIGURATION OF EUT .................................................................................... 12 8.2 SUPPORT EQUIPMENT ..................................................................................................... 13 8.3 EUT OPERATING CONDITION ........................................................................................... 14 9. APPLICABLE LIMITS AND TEST RESULTS ........................................................... 16 9.1 6dB BANDWIDTH ................................................................................................................ 16 9.2 MAXIMUM PEAK OUTPUT POWER ................................................................................... 20 9.3 DUTY CYCLE ...................................................................................................................... 26 9.4 POWER SPECTRAL DENSITY ........................................................................................... 30 9.5 CONDUCTED SPURIOUS EMISSION ................................................................................ 34 9.6 RADIATED EMISSIONS ...................................................................................................... 40 9.7 POWERLINE CONDUCTED EMISSIONS ........................................................................... 54 10. ANTENNA REQUIREMENT ..............................................................…

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Test Setup Photos

Page: 57 / 60 Report No.: T201209N02-RP1 Ref. No.: Rev.: 00 APPENDIX I SETUP PHOTOS RADIATED EMISSION MEASUREMENT SETUP Below 1GHz Page: 58 / 60 Report No.: T201209N02-RP1 Ref. No.: Rev.: 00 Page: 59 / 60 Report No.: T201209N02-RP1 Ref. No.: Rev.: 00 RADIATED RF MEASUREMENT SETUP Above 1GHz Page: 60 / 60 Report No.: T201209N02-RP1 Ref. No.: Rev.: 00 RF CONDUCTED SETUP

Contact Information

Applicant

Tracy Cheng(Head of Manufacturing)
[email protected]6502514409Fax: 6502514409

Technical Contact

Compliance Certification Services Inc. Tainan Lab.Daphne Liang
[email protected]886-6-580-2201

No.8,Jiucengling, Xinhua Dist., · Taiwan

Non-Technical Contact

Compliance Certification Services Inc. Tainan Lab.Daphne Liang
[email protected]886-6-580-2201

Test Firm

Compliance Certification Services Inc.Tommy WU
[email protected]886-6-5802201Fax: 886-6-5802202

Technical Specifications

#Rule PartsFrequency RangePower Output
115C2.40 GHz - 2.48 GHz1.10 mW
Confidentiality
Long Term
Grant Notes
Power Output is conducted. This is a portable device. The antenna(s) used for this transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. End users must be provided with specific operating instructions for satisfying RF exposure compliance.

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