IMG · Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Physical Medicine · 21 CFR 890.5860 · Class 2
Overview
| Product Code | IMG |
|---|---|
| Device Name | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Regulation | 21 CFR 890.5860 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
| 3rd-Party Reviewable | Yes |
Identification
An ultrasound and muscle stimulator 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. The device also passes electrical currents through the body area to stimulate or relax muscles.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 55)
Showing 20 most recent of 55 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K244041 | Ultrasound Therapy Workstation (XMS-UET2) | Xemis Medical Technology (Shenzhen) Co., Ltd. | Oct 7, 2025 | SESE |
| K153559 | OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System | Accelerated Care Plus (Acp) | Aug 26, 2016 | SESE |
| K150436 | ComboRehab | Shenzhen Dongdixin Technology Co., Ltd. | Nov 13, 2015 | SESE |
| K150353 | BTL-4000 | BTL Industries, Inc. | Nov 13, 2015 | SESE |
| K120217 | SONICSTIMU COMBO THERAPEUTIC DEVICE | Shenzhen Dongdixin Technology Co., Ltd. | Nov 21, 2012 | SESE |
| K121059 | SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM | Zimmer Medizinsystems GmbH | Aug 7, 2012 | SESE |
| K102524 | FUTURA | Dr. Oliver Wenker, M.D., M.B.A. | Nov 3, 2011 | SESE |
| K111482 | SONICATOR PLUS 920 | Mettler Electronics Corp. | Aug 25, 2011 | SESE |
| K102190 | WINSTIM | Johari Digital Healthcare , Ltd. | Mar 17, 2011 | SESE |
| K092627 | CT2011 SONICSTIMU PAIN RELIEF DEVICE | Shenzhen Dongdixin Technology Co., Ltd. | Jan 14, 2010 | SESE |
| K071137 | SONICATOR PLUS 940, MODEL ME940 | Mettler Electronics Corp. | Aug 1, 2007 | SESE |
| K063728 | TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM | Alfa Tech Medical Systems, Ltd. | Apr 4, 2007 | SESE |
| K063135 | SONIC-STIM | Naimco, Inc. | Feb 5, 2007 | SESE |
| K052340 | DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM | Alfa Tech Medical Systems, Ltd. | Dec 9, 2005 | SESE |
| K040285 | VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER | Chattanooga Group | Apr 12, 2004 | SESE |
| K040121 | DERMAWAVE 5000 COMBI MAX SYSTEM | Dermawave, LLC | Mar 17, 2004 | SESE |
| K031077 | VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM | Chattanooga Group | Dec 11, 2003 | SESE |
| K030880 | VECTORSONIC, MODEL VU-270 | Metron Medical Australia, Pty, Ltd. | Apr 18, 2003 | SESE |
| K023050 | RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI | Reliant Technologies, Inc. | Feb 14, 2003 | SESE |
| K020119 | VECTORSONIC, MODEL VU-200 | Metron Medical Australia, Pty, Ltd. | Jul 22, 2002 | SESE |
Top Applicants
- Chattanooga Group, Inc. — 11 clearances
- Mettler Electronics Corp. — 6 clearances
- Rich-Mar Corp. — 5 clearances
- Excel Tech. , Ltd. — 3 clearances
- Henley Intl. — 3 clearances
