Vital Signs Patch System (VSP)
by Lifewatch Technologies, Ltd.
510(k) K132407
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK132407 | Date19 Dec 2014 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Vital Signs Patch System (in Short Vsp)
- 510(k) Number
- FDA Product Code
- DSI
- FDA applicant
- Lifewatch Technologies , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1025
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Vital Signs Patch System (VSP) is a continuous, non-invasive monitoring device classified as a Detector and Alarm for Arrhythmia. It is designed to measure and display electrocardiogram (ECG), heart rate, respiration rate, surface temperature, and arterial blood oxygen saturation (SpO₂) in clinical settings. The system is intended for use in adult patients aged 21 and above, as prescribed by a healthcare professional.
The VSP is supplied as a single-use, wearable patch system intended for use in clinical environments. It is not MRI-safe and is not defibrillation-proof, requiring caution in settings where defibrillation may be administered. The device operates under FDA 510(k) clearance (K132407) and falls under the regulatory category of Class II (DSI). Storage and handling instructions are not specified in the data, but standard medical device precautions should be followed.
Other devices from Lifewatch Technologies, Ltd.
Questions
AI-generated answers, 20 Sep 2026
What types of vital signs does the Vital Signs Patch System (VSP) monitor continuously and non-invasively?
The VSP continuously and non-invasively measures electrocardiogram (ECG), heart rate, respiration rate, surface temperature, and arterial blood oxygen saturation (SpO₂). These metrics are designed for use in clinical settings to provide comprehensive patient monitoring.
Is the Vital Signs Patch System (VSP) intended for use on patients of all ages, or is there a specific age restriction?
The VSP is specifically designed for use in adult patients aged 21 and above, as prescribed by a healthcare professional. It is not intended for pediatric or younger adult populations.
How is the Vital Signs Patch System (VSP) supplied, and is it meant for single-use or reusable applications?
The VSP is supplied as a single-use, wearable patch system. This means each patch is intended for one-time use in a clinical environment, ensuring patient safety and hygiene.
Are there any safety concerns related to the use of the Vital Signs Patch System (VSP) in environments where defibrillation may be required?
The VSP is not defibrillation-proof, so caution must be exercised when using it in settings where defibrillation may be administered. This means the device should not be relied upon as a barrier to defibrillation, and standard safety protocols should be followed.
What regulatory pathway was followed for the approval of the Vital Signs Patch System (VSP), and what classification does it hold?
The VSP was cleared through the FDA’s 510(k) pathway under the classification of Class II (Detector and Alarm for Arrhythmia). The clearance number is K132407, and it falls under the regulatory category of DSI (Detector and Signal Processor).