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Empi Model 710, Nms

by Empi

510(k) K811395

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK811395 Date24 Aug 1981ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
IPF
Device class
Class II
Regulation
21 CFR Part 890.5850
Advisory committee
Physical Medicine
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Similar devices

Other devices filed under FDA product code IPF (Stimulator, Muscle, Powered).

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