IMI · Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Physical Medicine · 21 CFR 890.5300 · Class 2
Overview
| Product Code | IMI |
|---|---|
| Device Name | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Regulation | 21 CFR 890.5300 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
| 3rd-Party Reviewable | Yes |
Identification
An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 89)
Showing 20 most recent of 89 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240788 | Ultrasound Stimulator | Jkh Health Co., Ltd. | Jun 4, 2025 | SESE |
| K230472 | Sonopuls 190 | Enraf-Nonius, B.V. | Oct 24, 2023 | SESE |
| K222098 | ManaSport+ | Manamed, Inc. | Mar 8, 2023 | SESE |
| K210284 | ManaSport | Manamed, Inc. | Apr 26, 2022 | SESE |
| K202788 | Sonomed IV, Sonomed V | Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto | Dec 23, 2021 | SESE |
| K160378 | BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) | Brh Medical , Ltd. | Aug 25, 2017 | SESE |
| K161628 | JAS Pulse(TM) Ultrasonic Therapy | Bonutti Research, Inc. | Nov 10, 2016 | SESE |
| K160075 | Accent XL | Alma Lasers, Inc. | Aug 17, 2016 | SESE |
| K161502 | MC1 Plus | General Project S.R.L. | Aug 16, 2016 | SESE |
| K142976 | UltraTENS | Shenzhen Dongdixin Technology Co., Ltd. | Aug 26, 2015 | SESE |
| K131309 | SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ | Ibramed Equipamentos Medicos | Jan 27, 2014 | SESE |
| K130888 | SONOPULSE/ SONOPULSE III | Ibramed- Industria Brazileria DE Equipamentos Medi | Jan 9, 2014 | SESE |
| K124010 | ACCUSONIC ADVANTAGE | Metron Medical Australia, Pty, Ltd. | Aug 23, 2013 | SESE |
| K120171 | ACCUSONIC ADVANTAGE | Metron Medical Australia, Pty, Ltd. | May 4, 2012 | SESE |
| K112520 | US-101L, US-103S | Ito Co., Ltd. | Oct 26, 2011 | SESE |
| K091615 | MED CONTOUR | General Project S.R.L. | May 6, 2010 | SESE |
| K090542 | SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900 | Sun-Rain System Corp. | Oct 23, 2009 | SESE |
| K062256 | HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM | Hill Laboratories Co. | Feb 26, 2007 | SESE |
| K053041 | MED SCULPT | General Project S.R.L. | Aug 2, 2006 | SESE |
| K052934 | DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM | S.O.R. Internacional, S.A. | Jun 12, 2006 | SESE |
Top Applicants
- Metron Medical Australia, Pty, Ltd. — 9 clearances
- Rich-Mar Corp. — 9 clearances
- Chattanooga Group, Inc. — 7 clearances
- Mettler Electronics Corp. — 7 clearances
- General Project S.R.L. — 3 clearances
