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…
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.
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (2), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for BioButton Rechargeable Device, Multi-Patient | Listed by | Biointellisense Inc., United States |
| FDA product code | DRG |
| Device type | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2910 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K241101 |
| Record published | 2025-02-11 |
Specifications
Specifications | MRI safety | MR Unsafe |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature 10 to 25 °C; Storage environment humidity 10 to 75 % RH |
| Packaging | 12count inner carton of 12, 16pack master carton of 16 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.