Identifiers
- 510(k) Number
- K811395 FDA 510(k)
- FDA Product Code
- IPF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5850 FDA 510(k)
- Regulation Number
- 890.5850 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EMPI MODEL 710, NMS is a muscle stimulator, powered, classified as a Class 2 medical device under FDA regulation 890.5850. It is intended for use in physical medicine and neurology applications, as reviewed by the Physical Medicine advisory committee.
The device is supplied as a single-use item and requires proper storage conditions. It is not MRI safe and has received FDA 510(k) clearance (K811395) on August 24, 1981, following a Traditional review process.
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 MODEL 710, NMS (K811395) — FDA 510 (k) | Innolitics, EMPI MODEL 710, NMS 510 (k) K811395 - FDA.report, PDF K811395 - EMPI MODEL 710, NMS - 510kdatabase.net
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K811395 | Class II | Active |
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Manufacturer
- Manufacturer
- Empi
Sources (1)
- FDA 510(k) K811395 24 fields · synced Sep 21, 2026