FDA 510(k) · BioIntelliSense
K191614: BioSticker System (Biointellisense, Inc.)
Biointellisense, Inc. received FDA 510(k) K191614 for BioSticker System, with a decision date of Dec 18, 2019 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K191614 |
|---|---|
| Pathway | 510(k) |
| Applicant | Biointellisense, Inc. |
| Device name | BioSticker System |
| Product code | DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Regulation (21 CFR) | 870.2910 |
| Device class | Class 2 |
| Date received | Jun 18, 2019 |
| Decision date | Dec 18, 2019 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The BioSticker System is a remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This can include heart rate, respiratory rate, and skin temperature. Data are transmitted via wireless connection from the BioSticker for storage and analysis. The device is intended for use on general care patients who are 21 years of age or older as a general patient monitor, to provide physiological information. The data from the BioSticker System are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended to measure physiological parameters while the patient undergoes significant motion or is active. The device is not intended for use on critical care patients.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
No predicate numbers were parsed for this record. The FDA summary, if available, names the predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DRG is "Transmitters And Receivers, Physiological Signal, Radiofrequency", class 2, 21 CFR 870.2910.
Our labels for filtering: claim Remote / vital-sign monitoring, sensor Unknown. These are heuristics, not FDA fields.