VitalPatch 7D Biosensor - Single, VitalPatch 7D Biosensor - Bag of 20
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K190916 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 7D Biosensor is a radiofrequency physiological signal transmitter and receiver (Class II device), designed to continuously monitor and transmit physiological data. It records electrocardiogram (ECG), skin/ambient temperature, and tri-axial accelerometer data wirelessly via Bluetooth Low Energy for remote analysis.
Supplied as single-use units or pre-packaged bags of 20, the device is intended for clinical and home monitoring of general care patients. It operates in non-MRI environments and requires no sterilization, as it is intended for single-use. Authorized under FDA 510(k) clearance (K190916), it adheres to 21 CFR 870.2910 for radiofrequency physiological signal transmitters. Storage follows standard single-use medical device protocols.
Frequently asked questions
What types of physiological data does the VitalPatch 7D Biosensor monitor continuously, and how is it transmitted?
The VitalPatch 7D Biosensor continuously monitors electrocardiogram (ECG), skin/ambient temperature, and tri-axial accelerometer data. It transmits this data wirelessly via Bluetooth Low Energy for remote analysis, making it suitable for both clinical and home monitoring environments.
Is the VitalPatch 7D Biosensor reusable, and if not, what are the storage requirements?
The VitalPatch 7D Biosensor is designed for single-use only, so it does not require sterilization. Storage follows standard protocols for single-use medical devices, ensuring it remains uncontaminated and functional until use.
What packaging options are available for the VitalPatch 7D Biosensor, and how does this affect clinical workflows?
The device is available as single-use units or in pre-packaged bags of 20, which streamlines inventory management and reduces preparation time in clinical or home settings. This makes it convenient for bulk purchases while maintaining single-patient use.
Can the VitalPatch 7D Biosensor be used in an MRI environment, and if not, why?
No, the VitalPatch 7D Biosensor is not intended for MRI environments. This limitation is due to its radiofrequency components, which could interfere with MRI systems or pose safety risks during scanning.
What regulatory pathway was followed for FDA clearance of the VitalPatch 7D Biosensor, and what does this mean for its use?
The device was cleared via a traditional 510(k) pathway (K190916), classified as substantially equivalent under 21 CFR 870.2910 for radiofrequency physiological signal transmitters. This means it meets FDA standards for safety and effectiveness as a Class II medical device, authorized for clinical and home monitoring of general care patients.
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: VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20, VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single ..., MediBioSense VitalPatch
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190916 | Class II | Active |
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Manufacturer
- Manufacturer
- VitalConnect, Inc.
Sources (1)
- FDA 510(k) K190916 24 fields · synced Sep 20, 2026