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VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch …

FDA 510(k)

Class II (US FDA 510(k))

510(k) K192757

by VitalConnect, Inc.

Identifiers

510(k) Number
K192757 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 5D and 7D Biosensors are radiofrequency physiological signal transmitters and receivers, classified under 21 CFR 870.2910. These single-use adhesive patches continuously monitor vital signs, including electrocardiogram (ECG), respiration rate, and activity levels, enabling remote patient monitoring for cardiovascular assessment.

Supplied as single units or in bags of 20, these biosensors are intended for non-invasive, wearable use on the chest. They operate as part of a remote monitoring system and are regulated under FDA 510(k) clearance (K192757) as substantially equivalent devices. No sterilization or reusable processing is required; each patch is designed for single-use only. Compatibility with MRI environments is not specified.

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 5D Biosensor - single, VitalPatch 7D Biosensor - single ..., VitalPatch 5D Biosensor - Single, VitalPatch 7D… - FDA.report, MediBioSense VitalPatch

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
VitalConnect, Inc.

Sources (1)

  • FDA 510(k) K192757 24 fields · synced Sep 18, 2026