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Omnistim III Interferential Therapy

by Physio Technology, Inc.

510(k) K841278

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 NumberK841278 Date24 Apr 1984ClearedStatusActive

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  • Withdrawn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)

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, 28 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 Omnistim III Interferential Therapy device is an interferential therapy device used for physical medicine applications. It is a substantially equivalent device cleared through the traditional 510(k) pathway.

Manufactured by Physio Technology, Inc., the device received FDA 510(k) clearance under k-number K841278 with product code IPF. It was cleared on April 24, 1984, following submission on March 28, 1984, and is authorized for distribution in the United States.

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Questions

AI-generated answers, 28 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 Omnistim III Interferential Therapy device used for?

    The Omnistim III Interferential Therapy device is used for physical medicine applications as an interferential therapy system, delivering electrical stimulation for therapeutic purposes in clinical settings.

  • How was the Omnistim III Interferential Therapy device authorized for use in the United States?

    The device received FDA 510(k) clearance under k-number K841278 on April 24, 1984, following a traditional 510(k) submission on March 28, 1984, and was determined to be substantially equivalent to a predicate device.

  • Who manufactures the Omnistim III Interferential Therapy device and where is it located?

    The Omnistim III Interferential Therapy device is manufactured by Physio Technology, Inc., located at 4221 Richmond Rd., NW, Walker, MI 49534, United States.