Identifiers
- 510(k) Number
- K854775 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
- SN FDA 510(k)
The EMPI Model 730 NMS is a neurostimulation device used in physical medicine applications. It is designed to provide electrical nerve stimulation for therapeutic purposes.
This device is supplied by Empi and received FDA 510(k) clearance with K-number K854775. The Model 730 NMS is part of the IPF product code category and was reviewed under the Physical Medicine advisory committee.
Frequently asked questions
What is the EMPI Model 730 NMS used for?
The EMPI Model 730 NMS is a neurostimulation device designed for therapeutic electrical nerve stimulation in physical medicine applications. It helps manage pain and rehabilitate patients through targeted nerve stimulation.
How is the EMPI Model 730 NMS supplied?
The EMPI Model 730 NMS is supplied by Empi, a medical device manufacturer. The device comes in a standard configuration suitable for clinical use in physical medicine settings.
What is the regulatory status of the EMPI Model 730 NMS?
The EMPI Model 730 NMS received FDA 510(k) clearance with K-number K854775. It is classified under product code IPF and was reviewed under the Physical Medicine advisory committee.
Is the EMPI Model 730 NMS reusable or single-use?
The device data does not specify whether the EMPI Model 730 NMS is designed for single-use or multiple uses. Clinicians should refer to the manufacturer's instructions for use to determine the appropriate handling and disposal 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: PDF K854775 EMPI MODEL 730 NMS - 510kdatabase.net, Empi Model 730 Nms 510 (k) FDA Premarket Notification K854775 EMPI, EMPI FDA Filings - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K854775 | Class II | Active |
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Manufacturer
- Manufacturer
- Empi
Sources (1)
- FDA 510(k) K854775 24 fields · synced Sep 26, 2026