FDA 510(k) · VitalConnect
K190916: VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 (Vitalconnect, Inc.)
Vitalconnect, Inc. received FDA 510(k) K190916 for VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20, with a decision date of Jun 7, 2019 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K190916 |
|---|---|
| Pathway | 510(k) |
| Applicant | Vitalconnect, Inc. |
| Device name | VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 |
| Product code | DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Regulation (21 CFR) | 870.2910 |
| Device class | Class 2 |
| Date received | Apr 9, 2019 |
| Decision date | Jun 7, 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 VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This can include heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, body temperature, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data are transmitted wirelessly from the VitalConnect Sensor for storage and analysis. The VitalConnect Platform can include the ability to notify healthcare professionals when physiological data fall outside selected parameters. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The data from the VitalConnect Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. 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
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- K183078 VitalConnect Platform, VitalPatch Biose… (VitalConnect)
Later records that cite K190916
- K191882 Masimo Centroid System (Masimo, Apr 22, 2020, MWI)
- K193343 Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) (VitalConnect, Apr 20, 2020, DRG)
- K192757 VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor bag of 20, VitalPatch 7D Biosensor bag of 20 (VitalConnect, Feb 6, 2020, DRG)
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.