Identifiers
- 510(k) Number
- K203158 FDA 510(k)
- FDA Product Code
- GXY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1320 FDA 510(k)
- Regulation Number
- 882.1320 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
BioWave BioWraps are wearable compression electrode garments designed for neuromodulation therapy. They incorporate permanent silver fabric electrodes to deliver high-frequency electrical signals, targeting deeper tissue penetration compared to traditional hydrogel electrodes. The device is classified under the product code GXY and is intended for use in neuromodulation applications, particularly for chronic pain management in hard-to-reach areas of the body.
BioWave BioWraps are supplied as reusable garments and are intended for use in clinical settings where neuromodulation is administered. The device is authorized under an FDA 510(k) clearance (K203158) and is regulated as a substantially equivalent device to a predicate under the Traditional 510(k) pathway. No specific sterility or MRI safety information is provided in the available data, but the device is designed for direct patient application and should be handled according to standard medical device protocols.
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: Silver BioWraps for Drug-Free Pain Relief | BioWave, BioWrap - Model RX -Wearable Electrode Garments, BioWave BioWraps (K203158) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203158 | Class II | Active |
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Manufacturer
- Manufacturer
- BioWave Corporation
Sources (1)
- FDA 510(k) K203158 24 fields · synced Sep 19, 2026