Identifiers
- 510(k) Number
- K183078 FDA 510(k)
- FDA Product Code
- DRG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2910 FDA 510(k)
- Regulation Number
- 870.2910 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The VitalPatch Biosensor is a wireless, battery-operated wearable device classified as a transmitter and receiver for physiological signals, designed to monitor and transmit real-time biometric data. It functions as a component of the VitalConnect Platform, capturing continuous readings such as electrocardiogram (ECG), heart rate, respiratory rate, skin/ambient temperature, activity, and posture for cardiovascular assessment.
The device is intended for single-use and is worn on the torso, enabling remote monitoring of patients in clinical settings such as hospitals and healthcare facilities. It operates via radiofrequency transmission and is regulated under FDA 510(k) clearance (K183078) and the Medical Device Directive (MDD). The device is non-sterile and requires proper storage as specified by the manufacturer.
Frequently asked questions
What types of physiological data does the VitalPatch Biosensor monitor, and how is this information transmitted?
The VitalPatch Biosensor continuously captures real-time biometric data including electrocardiogram (ECG), heart rate, respiratory rate, skin/ambient temperature, activity levels, and posture. These signals are wirelessly transmitted via radiofrequency to enable remote monitoring, making it suitable for clinical settings like hospitals.
Is the VitalPatch Biosensor intended for reuse, or is it designed for single-use only?
The VitalPatch Biosensor is explicitly designed for single-use only, as stated in the manufacturer’s specifications. This ensures patient safety and hygiene in clinical environments.
How should the VitalPatch Biosensor be stored, and is it sterile?
The device is non-sterile, so it must be stored according to the manufacturer’s guidelines to maintain its integrity. Proper storage conditions (e.g., temperature, humidity, and protection from contamination) are critical, as outlined by VitalConnect, Inc.
What regulatory pathways has the VitalPatch Biosensor followed, and where is it manufactured?
The device has received FDA 510(k) clearance (K183078) and complies with the Medical Device Directive (MDD). It is manufactured by VitalConnect, Inc., headquartered at 224 Airport Pkwy., Suite 300, San Jose, CA 95110.
Where exactly is the VitalPatch Biosensor worn on the patient’s body, and how does this affect its functionality?
The device is worn on the torso, where it adheres to monitor cardiovascular parameters effectively. This placement allows for stable ECG readings, respiratory tracking, and posture assessment, ensuring accurate remote monitoring for clinical use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Home - VitalConnect, VitalConnect, Instructions for Use, VitalPatch® Biosensor, VitalConnect Platform, VitalPatch Biosensor (K183078) — FDA 510(k ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K183078 | Class II | Active |
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Manufacturer
- Manufacturer
- VitalConnect, Inc.
Sources (2)
- FDA 510(k) K183078 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026