FDA 510(k) · HMicro
K172011: LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) (Hmicro, Inc.)
Hmicro, Inc. received FDA 510(k) K172011 for LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System), with a decision date of Jun 14, 2018 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K172011 |
|---|---|
| Pathway | 510(k) |
| Applicant | Hmicro, Inc. |
| Device name | LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) |
| Product code | DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Regulation (21 CFR) | 870.2910 |
| Device class | Class 2 |
| Date received | Jul 3, 2017 |
| Decision date | Jun 14, 2018 |
| 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 Vios Monitoring The LifeSignals WiPatch & System (VMS) is intended WiApp system is intended for for use by medically spot check and short-term qualified personnel for monitoring of ECG & heart physiological and vital rate of patients at rest or signs monitoring of adult patients who can be (18+) patients in transported within the range healthcare facilities. It is of the antenna network. The indicated for use in WiPatch & WiApp system has monitoring of ECG, heart visual and audio alarms to rate, pulse rate, alert clinical personnel when functional oxygen heart rate falls outside the set saturation of arterial limits. The device is intended hemoglobin, and axillary for use on general care temperature. patients of 18 years or older. The device is not intended for use on critical care patients. Intended Population Adults ≥ 18 Adults ≥ 18 Intended Use Environment Healthcare facility Healthcare facility or clinical pharmacological unit Heart Rate Yes Yes Temperature No Yes ECG Display ECG-A and ECG-B Channel I and II SpO2 No Optional Pulse Rate No Optional NiBP No Optional Sensor Wireless patch design— Wireless patch design— RF/Wi-Fi 2.4 GHz 802.11b RF/Bluetooth 2.4 GHz Wear duration 72 hours (maximum) Hardware Platform Standard commercial iOS Standard commercial IT tablet (iPad, iPad2, iPad Air, equipment iPad Air2) TECHNICAL SPECIFICATION (HEART RATE) Display Range 30 to 250 BPM Accuracy +/- 3 BPM Note 1 Resolution 1 BPM
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.
Later records that cite K172011
- K200690 LifeSignals ECG Remote Monitoring Patch Platform (LifeSignals, Jul 15, 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.