Identity
- Trade Name
- BioButton Charging Station FDA UDI
- Generic Name
- Wearable multiple physiological parameter recorder, reusable FDA UDI
- Device Name
- The BioButton Charging Station is intended to be used by trained professionals to charge multiple compatible rechargeable wearable devices simultaneously in healthcare or other care facilities. The charger is not intended to be used at the patient home. FDA UDI
- Model / Reference
- CRG-12685 FDA UDI
- Description
- The BioButton Charging Station is intended to be used by trained professionals to charge multiple compatible rechargeable wearable devices simultaneously in healthcare or other care facilities. The charger is not intended to be used at the patient home. FDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 00850005949596 FDA UDI
- 510(k) Number
- K241101 FDA UDI
- FDA Product Code
- DRG FDA UDIDRT FDA UDI
- GMDN Term
- Wearable multiple physiological parameter recorder, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2910 FDA UDI870.2300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Wearable multiple physiological parameter recorder, reusable
BioButton Charging Station 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
- SansaTM — Huxley Medical · Class II
- 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
K241101 also covers:
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 f8999268-90bf-4d2d-8d0a-03839dc48b47 36 fields · synced Sep 18, 2026