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SeliTherm, Model C100

by Selicor, Inc.

510(k) K030382

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 NumberK030382 Date1 Apr 2003ClearedStatusActive

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  • Withdrawn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, 26 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 SeliTherm, Model C100 is a shortwave diathermy device that generates deep tissue heating to treat pain, muscle spasms, and joint contractures. It is classified as a Class II medical device with a product code of IMJ and is intended for use in applying therapeutic deep heat in physical medicine.

The device is manufactured by Selicor, Inc. and received FDA 510(k) clearance with K number K030382 on April 1, 2003, as substantially equivalent. It is not MRI safety specified and is not indicated as single-use or reusable. The device is stored at the manufacturer's facility in Austin, Texas, and is authorized for use in physical medicine applications.

Other devices from Selicor, Inc.