Identity
- Trade Name
- BioButton At-Home Kit with Power Adaptor FDA UDI
- Generic Name
- Wearable multiple physiological parameter recorder, reusable FDA UDI
- Device Name
- BioButton At-Home Kit with Power Adaptor FDA UDI
- Model / Reference
- KIT-BBR-3763-1 FDA UDI
- Description
- BioButton At-Home Kit with Power Adaptor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850005949312 FDA UDI
- 510(k) Number
- K212957 FDA UDI
- FDA Product Code
- DRG FDA UDI
- GMDN Term
- Wearable multiple physiological parameter recorder, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2910 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Wearable multiple physiological parameter recorder, reusable
BioButton At-Home Kit with Power Adaptor by Biointellisense Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wearable multiple physiological parameter recorder, reusable.
- BioButton At-Home Kit — BIOINTELLISENSE, INC. · Class II
- circul pro, x-large — Bodimetrics, LLC · Class II
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- ANNE™ One — Sibel Health Inc. · Class II
- AcuPebble — Acurable Limited · Class II
- Wearable Patch — ATLAS LIFT TECH, INC. · Class I
- BioButton (Reprocessed, NF Version) — BIOINTELLISENSE, INC. · Class II
- SOMNOwatch plus ACTI — Somnomedics GmbH · Class II
Cleared under the same submission
K212957 also covers:
- BioButton At-Home Kit with Adhesives and BioButton — BIOINTELLISENSE INC.
- BioButton At-Home Kit with Power Adaptor and Adhesives — BIOINTELLISENSE INC.
- BioButton At-Home Kit with Power Adaptor, Adhesives and BioButton — BIOINTELLISENSE INC.
- BioButton (In Bulk Packaging) — BIOINTELLISENSE, INC.
- BioButton At-Home Kit — BIOINTELLISENSE, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biointellisense Inc.
Sources (1)
- FDA UDI db45fb3c-9ce7-4d71-9968-71cb2dd4604c 34 fields · synced Sep 18, 2026