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Modified Omnistim Electrical Muscle Stimulator

by Physio Technology, Inc.

510(k) K874076

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK874076 Date4 Jan 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Modified Omnistim(Tm) Electrical Muscle Stimulator
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, 19 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 Modified Omnistim Electrical Muscle Stimulator is a powered medical device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is classified as a Class 2 device under Regulation 890.5850 and falls under the category of Stimulator, Muscle, Powered.

The device is supplied as a single-use or reusable unit, depending on the model, and is intended for use in physical medicine. It is not MRI safe, and storage requirements are not specified in the provided data. The device has received FDA 510(k) clearance (K874076) with a decision of Substantially Equivalent (SESE) on January 4, 1988.

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Questions

AI-generated answers, 19 Sep 2026

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

  • What is the Modified Omnistim Electrical Muscle Stimulator intended for?

    The device is intended for medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area, and is used in physical medicine as a powered muscle stimulator.

  • Is the Modified Omnistim Electrical Muscle Stimulator supplied as single-use or reusable?

    The device is supplied as either a single-use or reusable unit, depending on the specific model, as indicated in the device description.

  • What regulatory pathway was used for the Modified Omnistim Electrical Muscle Stimulator?

    The device received FDA 510(k) clearance via the traditional pathway, with clearance number K874076 and a decision of Substantially Equivalent on January 4, 1988.

  • Is the Modified Omnistim Electrical Muscle Stimulator safe for use in an MRI environment?

    The device is not MRI safe, as explicitly stated in the device description under specifications.

  • What is the product code and classification for the Modified Omnistim Electrical Muscle Stimulator?

    The device has product code IPF and is classified as a Class 2 device under Regulation 890.5850, falling under the category of Stimulator, Muscle, Powered.