Identifiers
- 510(k) Number
- K112934 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)
Neurotech Recovery is a medical device listed under product code GXY and identified by K112934. It is intended for home use as a neuro‑rehabilitation aid.
The device is cleared through an FDA 510(k) Traditional submission (decision date 2012‑01‑20) and may be sold only with a prescription from a licensed practitioner. Use is limited to the gel pads supplied by Bio‑Medical Research Ltd., which include their own cleaning and storage instructions.
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: NEUROTECH RECOVERY (K112934) — FDA 510 (k) | Innolitics, PDF Neurotech Recovery - Back, Neurotech Recovery - Back Instructions For Use Manual, PDF K112934 - Neurotech Recovery
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112934 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio-Medical Research, Ltd.
Sources (1)
- FDA 510(k) K112934 24 fields · synced Sep 21, 2026