Product code IMG
- Device name
- Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.5860
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K244041 | Ultrasound Therapy Workstation (XMS-UET2) | Xemis Medical Technology (Shenzhen) Co., Ltd. | 2025-10-07 |
| K153559 | OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System | Accelerated Care Plus (Acp) | 2016-08-26 |
| K150436 | ComboRehab | Shenzhen Dongdixin Technology Co., Ltd. | 2015-11-13 |
| K150353 | BTL-4000 | BTL Industries, Inc. | 2015-11-13 |
| K120217 | SONICSTIMU COMBO THERAPEUTIC DEVICE | Shenzhen Dongdixin Technology Co., Ltd. | 2012-11-21 |
| K121059 | SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM | Zimmer Medizinsystems GmbH | 2012-08-07 |
| K102524 | FUTURA | Dr. Oliver Wenker, M.D., M.B.A. | 2011-11-03 |
| K111482 | SONICATOR PLUS 920 | Mettler Electronics Corp. | 2011-08-25 |
| K102190 | WINSTIM | Johari Digital Healthcare , Ltd. | 2011-03-17 |
| K092627 | CT2011 SONICSTIMU PAIN RELIEF DEVICE | Shenzhen Dongdixin Technology Co., Ltd. | 2010-01-14 |
| K071137 | SONICATOR PLUS 940, MODEL ME940 | Mettler Electronics Corp. | 2007-08-01 |
| K063728 | TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM | Alfa Tech Medical Systems, Ltd. | 2007-04-04 |
| K063135 | SONIC-STIM | Naimco, Inc. | 2007-02-05 |
| K052340 | DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM | Alfa Tech Medical Systems, Ltd. | 2005-12-09 |
| K040285 | VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER | Chattanooga Group | 2004-04-12 |
| K040121 | DERMAWAVE 5000 COMBI MAX SYSTEM | Dermawave, LLC | 2004-03-17 |
| K031077 | VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM | Chattanooga Group | 2003-12-11 |
| K030880 | VECTORSONIC, MODEL VU-270 | Metron Medical Australia, Pty, Ltd. | 2003-04-18 |
| K023050 | RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI | Reliant Technologies, Inc. | 2003-02-14 |
| K020119 | VECTORSONIC, MODEL VU-200 | Metron Medical Australia, Pty, Ltd. | 2002-07-22 |
| K001166 | ULTRA V THERAPEUTIC ULTRASOUND | Excel Tech. , Ltd. | 2000-07-07 |
| K982317 | VECTRA COMBO | Chattanooga Group, Inc. | 1999-02-01 |
| K982830 | FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO | Chattanooga Group, Inc. | 1998-11-06 |
| K953614 | FORTE | Chattanooga Group, Inc. | 1995-10-27 |
| K951746 | FORTE CB | Chattanooga Group, Inc. | 1995-06-21 |
| K943469 | SONICATOR 730 | Mettler Electronics Corp. | 1994-08-29 |
| K941561 | FORTE US | Chattanooga Group, Inc. | 1994-06-20 |
| K935728 | DYNATRON 150 | Dynatronics Corp. | 1994-04-26 |
| K940180 | FORTE US | Chattanooga Group, Inc. | 1994-04-15 |
| K934287 | DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR | Dynawave, Corp. | 1994-04-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08720618311139 | Sonopuls 494 | Enraf-Nonius B.V. | 2025-02-11 |
| 00850030915214 | Richmar | South Dakota Partners Inc. | 2023-08-02 |
| 00850030915191 | Richmar | South Dakota Partners Inc. | 2023-08-02 |
| 00850030915221 | Richmar | South Dakota Partners Inc. | 2023-08-02 |
| 00190446780601 | CHATTANOOGA | DJO, LLC | 2023-04-25 |
| 00092237623817 | TheraTouch UX2 | Drive Devilbiss Healthcare | 2022-09-07 |
| 00092237901069 | Winner Evo CM2 - 120V | Drive Devilbiss Healthcare | 2018-09-27 |
| 00092237901076 | Winner Evo CM2 - 220V | Drive Devilbiss Healthcare | 2018-09-27 |
| 00850958007961 | WINNER EVO PACKAGE | Drive Devilbiss Healthcare | 2016-11-21 |
| 00850958007954 | WINNER EVO PACKAGE | Drive Devilbiss Healthcare | 2016-11-21 |
| 00850958007947 | WINNER EVO PACKAGE | Drive Devilbiss Healthcare | 2016-11-21 |
| 00850958007930 | WINNER EVO PACKAGE | Drive Devilbiss Healthcare | 2016-11-21 |
| 00850958007923 | WINNER EVO PACKAGE | Drive Devilbiss Healthcare | 2016-11-21 |
| 00850958007916 | WINNER EVO PACKAGE | Drive Devilbiss Healthcare | 2016-11-21 |
| 00850958007909 | WINNER EVO PACKAGE | Drive Devilbiss Healthcare | 2016-11-21 |
| 00850958007619 | WINNER EVO PACKAGE | Drive Devilbiss Healthcare | 2016-11-21 |
| 00850958007978 | WINNER EVO PACKAGE | Drive Devilbiss Healthcare | 2016-11-21 |
| 00850958007985 | WINNER EVO PACKAGE | Drive Devilbiss Healthcare | 2016-11-21 |
| 00092237611548 | Roscoe Medical | Drive Devilbiss Healthcare | 2016-10-13 |
| 00092237618868 | Mountain Valley | Drive Devilbiss Healthcare | 2016-10-13 |
| 00092237616802 | Roscoe Medical | Drive Devilbiss Healthcare | 2016-10-13 |
| 00092237611630 | UltraTENSII | Drive Devilbiss Healthcare | 2016-10-13 |
| 00092237611562 | LG Med Supply | Drive Devilbiss Healthcare | 2016-10-13 |
| 00092237618721 | Direct Supply | Drive Devilbiss Healthcare | 2016-10-12 |
| 00092237616741 | Roscoe Medical | Drive Devilbiss Healthcare | 2016-10-12 |
| 00092237616444 | Roscoe Medical | Drive Devilbiss Healthcare | 2016-10-12 |
| 00092237616437 | Roscoe Medical | Drive Devilbiss Healthcare | 2016-10-12 |
| 00816864020678 | Applicator 9402 | METTLER ELECTRONICS CORP. | 2016-09-15 |
| 00816864020661 | Applicator 9401 | METTLER ELECTRONICS CORP. | 2016-09-15 |
| 00816864020210 | Sonicator Plus 920 | METTLER ELECTRONICS CORP. | 2016-09-15 |