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Omnisound 3000

by Physio Technology, Inc.

510(k) K883893

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 NumberK883893 Date1 Nov 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  • Withdrawn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
Omnisound(Tm) 3000
510(k) Number
FDA Product Code
IMG
Device Class
Class II
Regulation
21 CFR Part 890.5860
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Omnisound 3000 is an ultrasound and muscle stimulator designed for applying therapeutic deep heat. It functions as a physical medicine device to deliver targeted thermal energy to tissues.

This device is regulated under FDA 510K clearance as a class 2 medical device. It is identified by product code IMG and falls under regulation number 890.5860.

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