FDA 510(k) · Lifewatch Technologies
K132407: VITAL SIGNS PATCH SYSTEM (IN SHORT VSP) (Lifewatch Technologies , Ltd.)
Lifewatch Technologies , Ltd. received FDA 510(k) K132407 for VITAL SIGNS PATCH SYSTEM (IN SHORT VSP), with a decision date of Dec 19, 2014 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K132407 |
|---|---|
| Pathway | 510(k) |
| Applicant | Lifewatch Technologies , Ltd. |
| Device name | VITAL SIGNS PATCH SYSTEM (IN SHORT VSP) |
| Product code | DSI: Detector And Alarm, Arrhythmia |
| Regulation (21 CFR) | 870.1025 |
| Device class | Class 2 |
| Date received | Aug 2, 2013 |
| Decision date | Dec 19, 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
We could not extract the indications for this record. Check the FDA record for its summary or statement.
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 K132407
- K151835 Vital Signs Patch System (Lifewatch Technologies, Feb 5, 2016, DSI)
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 DSI is "Detector And Alarm, Arrhythmia", class 2, 21 CFR 870.1025.
Our labels for filtering: claim AFib / irregular rhythm, sensor Wrist PPG. These are heuristics, not FDA fields.