FDA 510(k) · Lifewatch Technologies
K151835: Vital Signs Patch System (Lifewatch Technologies , Ltd.)
Lifewatch Technologies , Ltd. received FDA 510(k) K151835 for Vital Signs Patch System, with a decision date of Feb 5, 2016 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K151835 |
|---|---|
| Pathway | 510(k) |
| Applicant | Lifewatch Technologies , Ltd. |
| Device name | Vital Signs Patch System |
| Product code | DSI: Detector And Alarm, Arrhythmia |
| Regulation (21 CFR) | 870.1025 |
| Device class | Class 2 |
| Date received | Jul 6, 2015 |
| Decision date | Feb 5, 2016 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Special |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The Vital Signs Patch (VSP) system is intended to be used on patients in a clinical environment for the continuous, non- invasive monitoring of ECG, Heart Rate (HR), respiration rate, surface temperature, and arterial blood oxygen saturation (intended use group adults 21 and above), when prescribed by a physician or other qualified healthcare professional. Contraindications: • The VSP is not intended for use by persons with any type of defibrillator, external or internal (ICD); the VSP must be detached from the patient before using a defibrillator on the patient • The VSP is not to be used in a magnetic resonance imaging (MRI) environment. The VSP device must be removed from the patient’s skin before he/she undergoes MRI procedure • The VSP is not a “life-saving” or therapeutic device; the VSP supplies vital signs data to a doctor or technician for the purpose of diagnosis by such (or other qualified) personnel • The VSP is not intended for use on patients with unhealed surgical incision/dressings on the thoracic or abdominal regions • The VSP is not intended for use on patients with skin or soft tissue damage on the area where the VSP is placed (such as burns, irritation, infections, wounds, etc.) • The VSP is not intended for use in the diagnosis of myocardial infarction or for chest pain monitoring. Warning: The temperature function of the Vital Signs Patch measures and reports surface temperature on the upper chest. Where direct measurements of body core temperature are required, it is recommended to utilize appropriate core temperature monitoring devices for this purpose.
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.
- K132407 VITAL SIGNS PATCH SYSTEM (IN SHORT VSP) (Lifewatch Technologies)
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.