FDA 510(k) · VitalConnect
K132447: VITALCONNECT PLATFORM BY VITAL CONNECT INC. (Vitalconnect, Inc.)
Vitalconnect, Inc. received FDA 510(k) K132447 for VITALCONNECT PLATFORM BY VITAL CONNECT INC., with a decision date of Apr 3, 2014 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K132447 |
|---|---|
| Pathway | 510(k) |
| Applicant | Vitalconnect, Inc. |
| Device name | VITALCONNECT PLATFORM BY VITAL CONNECT INC. |
| Product code | DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Regulation (21 CFR) | 870.2910 |
| Device class | Class 2 |
| Date received | Aug 6, 2013 |
| Decision date | Apr 3, 2014 |
| 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
STATEMENT 510(k) Number (if known): K132447 Device Name: VitalConnect Platform Indication for use: The VitalConnect Platform is a wireless monitoring system intended for use by healthcare professionals for unattended surveillance of physiological data within healthcare settings. This includes heart rate, electrocardiography (ECG), heart rate variability, respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data is transmitted wirelessly to a central location where it is stored for analysis. The VitalConnect Platform can be configured by Authorized Persons to notify healthcare professionals when physiological data falls outside selected parameters. The device is not intended to be used on critical care patients and is intended to supplement vital signs monitoring by healthcare professionals, not to replace current standards of care. The device is intended for use on general care patients and on patients who are 18 years of age or older. It is not intended for home use. Prescription Use X Over-The-Counter Use (Part 21 CFR 801 Subpart D) AND/OR (24 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Kenneth J. Cavanaugh -S
Extracted automatically from FDA's 510(k) summary with OCR. 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.
Later records that cite K132447
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.