Empi Logix Model 712 NMS, TENS
FDA 510(k)Class II (US FDA 510(k))
by Empi
Identifiers
- 510(k) Number
- K870168 FDA 510(k)
- FDA Product Code
- GZJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5890 FDA 510(k)
- Regulation Number
- 882.5890 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Empi Logix Model 712 is a neuromuscular stimulator and transcutaneous electrical nerve stimulator. It is designed to deliver electrical stimulation for therapeutic purposes.
This device is supplied as a medical unit and is subject to FDA 510k authorization. It is categorized under the neurology advisory committee for regulatory purposes.
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: EMPI LOGIX MODEL 712 NMS, TENS (K870168) — FDA 510(k ..., HaRi · EMPI LOGIX MODEL 712 NMS, TENS, 510(K) Premarket Notification - accessdata.fda.gov, HaRi · Empi, GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief | FDA ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K870168 | Class II | Active |
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Manufacturer
- Manufacturer
- Empi
Sources (1)
- FDA 510(k) K870168 24 fields · synced Sep 23, 2026