BioButton Rechargeable Device, Multi-Patient

Primary DI

10850005949449

Brand

BioButton Rechargeable Device, Multi-Patient

Company

BIOINTELLISENSE, INC.

Model

BBRM-B-I-N

Catalog number

N/A

Device 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.

Published

2025-02-11

Public version status

New

Distribution status

In Commercial Distribution

MRI safety

MR Unsafe

Rx

true

OTC

false

Sterile

false

Single use

false