Skip to content

Soundtek Model UT-4700

by Soundtek, Inc.

510(k) K864766

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 NumberK864766 Date12 Mar 1987ClearedStatusActive

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  • Withdrawn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
IMJ
Device Class
Class II
Regulation
21 CFR Part 890.5290
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Soundtek Model UT-4700 is a shortwave diathermy device classified under the nomenclature for diathermy, shortwave, intended for applying therapeutic deep heat. Diathermy devices generate heat within body tissues to relieve pain, reduce inflammation, and promote healing through electromagnetic energy at shortwave frequencies. This modality is commonly used in physical medicine to treat musculoskeletal conditions and soft tissue injuries.

The device is supplied as a reusable medical instrument and requires regulatory compliance under FDA 510(k) clearance (K864766), with a classification of Class II (IMJ). It is intended for use in clinical settings such as physical therapy or rehabilitation facilities, where trained professionals apply it under supervision. Sterility is not applicable, as the device is cleaned and maintained between uses. No MRI safety information is specified, and its dimensions or storage requirements are not detailed in the available data.