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BioButton Rechargeable Device, Multi-Patient

FDA UDI

Class II (US FDA UDI)

by Biointellisense, Inc.

Identity

Trade Name
BioButton Rechargeable Device, Multi-Patient FDA UDI
Generic Name
Wearable multiple physiological parameter recorder, reusable FDA UDI
Device Name
The BioButton System (Multi-patient) is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This could include heart rate, respiratory rate, skin temperature, and other data such as activity level, body position, sleep, and step and gait analysis. Data are securely transmitted via wireless connection for storage, review, analysis, and display. The Device can include the ability to display data and notify healthcare professionals when physiological data fall outside clinician-specified parameters. The data from the Device are intended as an aid to diagnosis, disease management, and treatment. The Device is intended for use on patients who are 18 years of age or older. The Device is not intended to output physiological measurements while the patient undergoes significant motion or is active. The Device is not intended for critical care. This Device is cleared in K241101 to be reprocessed and reused. FDA UDI
Model / Reference
BBRM-B-I-N FDA UDI
Description
The BioButton System (Multi-patient) is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This could include heart rate, respiratory rate, skin temperature, and other data such as activity level, body position, sleep, and step and gait analysis. Data are securely transmitted via wireless connection for storage, review, analysis, and display. The Device can include the ability to display data and notify healthcare professionals when physiological data fall outside clinician-specified parameters. The data from the Device are intended as an aid to diagnosis, disease management, and treatment. The Device is intended for use on patients who are 18 years of age or older. The Device is not intended to output physiological measurements while the patient undergoes significant motion or is active. The Device is not intended for critical care. This Device is cleared in K241101 to be reprocessed and reused. FDA UDI

Identifiers

Catalog Number
N/A FDA UDI
Primary DI / UDI-DI
00850005949442 FDA UDI
510(k) Number
K241101 FDA UDI
FDA Product Code
DRG FDA UDI
DRT 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
870.2300 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Wearable multiple physiological parameter recorder, reusable

BioButton Rechargeable Device, Multi-Patient 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.

Cleared under the same submission

K241101 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biointellisense, Inc.

Sources (1)

  • FDA UDI d8b87a45-97c5-4a72-9603-6db993751889 37 fields · synced Jun 8, 2026