FDA Product Code
FDA Product Code IMG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5860
510(k) Clearances — 55 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K244041 | Ultrasound Therapy Workstation (XMS-UET2) | Xemis Medical Technology (Shenzhen) Co., Ltd. | 2025-10-07 | Traditional | PDF ↗ |
| K153559 | OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System | Accelerated Care Plus (Acp) | 2016-08-26 | Traditional | PDF ↗ |
| K150353 | BTL-4000 | BTL Industries, Inc. | 2015-11-13 | Traditional | PDF ↗ |
| K150436 | ComboRehab | Shenzhen Dongdixin Technology Co., Ltd. | 2015-11-13 | Traditional | PDF ↗ |
| K120217 | SONICSTIMU COMBO THERAPEUTIC DEVICE | Shenzhen Dongdixin Technology Co., Ltd. | 2012-11-21 | Traditional | PDF ↗ |
| K121059 | SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM | Zimmer Medizinsystems GmbH | 2012-08-07 | Abbreviated | PDF ↗ |
| K102524 | FUTURA | Dr. Oliver Wenker, M.D., M.B.A. | 2011-11-03 | Traditional | PDF ↗ |
| K111482 | SONICATOR PLUS 920 | Mettler Electronics Corp. | 2011-08-25 | Special | PDF ↗ |
| K102190 | WINSTIM | Johari Digital Healthcare , Ltd. | 2011-03-17 | Special | PDF ↗ |
| K092627 | CT2011 SONICSTIMU PAIN RELIEF DEVICE | Shenzhen Dongdixin Technology Co., Ltd. | 2010-01-14 | Traditional | PDF ↗ |
| K071137 | SONICATOR PLUS 940, MODEL ME940 | Mettler Electronics Corp. | 2007-08-01 | Abbreviated | PDF ↗ |
| K063728 | TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM | Alfa Tech Medical Systems, Ltd. | 2007-04-04 | Traditional | PDF ↗ |
| K063135 | SONIC-STIM | Naimco, Inc. | 2007-02-05 | Traditional | PDF ↗ |
| K052340 | DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM | Alfa Tech Medical Systems, Ltd. | 2005-12-09 | Traditional | PDF ↗ |
| K040285 | VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER | Chattanooga Group | 2004-04-12 | Traditional | PDF ↗ |
| K040121 | DERMAWAVE 5000 COMBI MAX SYSTEM | Dermawave, LLC | 2004-03-17 | Traditional | PDF ↗ |
| K031077 | VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM | Chattanooga Group | 2003-12-11 | Traditional | PDF ↗ |
| K030880 | VECTORSONIC, MODEL VU-270 | Metron Medical Australia, Pty, Ltd. | 2003-04-18 | Special | PDF ↗ |
| K023050 | RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI | Reliant Technologies, Inc. | 2003-02-14 | Traditional | PDF ↗ |
| K020119 | VECTORSONIC, MODEL VU-200 | Metron Medical Australia, Pty, Ltd. | 2002-07-22 | Traditional | PDF ↗ |
| K001166 | ULTRA V THERAPEUTIC ULTRASOUND | Excel Tech. , Ltd. | 2000-07-07 | Traditional | PDF ↗ |
| K982317 | VECTRA COMBO | Chattanooga Group, Inc. | 1999-02-01 | Traditional | PDF ↗ |
| K982830 | FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO | Chattanooga Group, Inc. | 1998-11-06 | Traditional | PDF ↗ |
| K953614 | FORTE | Chattanooga Group, Inc. | 1995-10-27 | Traditional | PDF ↗ |
| K951746 | FORTE CB | Chattanooga Group, Inc. | 1995-06-21 | Traditional | PDF ↗ |
| K943469 | SONICATOR 730 | Mettler Electronics Corp. | 1994-08-29 | Traditional | PDF ↗ |
| K941561 | FORTE US | Chattanooga Group, Inc. | 1994-06-20 | Traditional | PDF ↗ |
| K935728 | DYNATRON 150 | Dynatronics Corp. | 1994-04-26 | Traditional | PDF ↗ |
| K940180 | FORTE US | Chattanooga Group, Inc. | 1994-04-15 | Traditional | PDF ↗ |
| K934287 | DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR | Dynawave, Corp. | 1994-04-04 | Traditional | PDF ↗ |
| K934846 | SONICATOR 716 | Mettler Electronics Corp. | 1994-03-23 | Traditional | PDF ↗ |
| K935271 | THERAPEUTIC ULTRASOUND AND STIMULATOR | Chattanooga Group, Inc. | 1994-02-02 | Traditional | PDF ↗ |
| K934845 | SONICATOR 715 | Mettler Electronics Corp. | 1994-01-21 | Traditional | PDF ↗ |
| K932937 | DYNATRON 800 | Dynatronics Corp. | 1993-10-08 | Traditional | PDF ↗ |
| K922036 | SONOPULS 591 | Henley Intl. | 1993-06-29 | Traditional | PDF ↗ |
| K921436 | SONICATOR PLUS | Mettler Electronics Corp. | 1993-04-27 | Traditional | PDF ↗ |
| K921952 | ULTRA III | Excel Tech. , Ltd. | 1993-03-09 | Traditional | PDF ↗ |
| K920939 | DYNATRON 300 ULRASOUND | Dynatronics Laser Corp. | 1993-03-04 | Traditional | PDF ↗ |
| K923797 | MODEL 25 THERAPEUTIC ULTRASOUND -- MODIFIED | Rich-Mar Corp. | 1992-11-06 | Traditional | PDF ↗ |
| K911733 | INTELECT, MODEL 245 | Chattanooga Group, Inc. | 1991-12-17 | Traditional | PDF ↗ |
| K902860 | INTELECT 170 | Chattanooga Group, Inc. | 1990-09-27 | Traditional | PDF ↗ |
| K902875 | INTELECT 750 MP | Chattanooga Group, Inc. | 1990-09-27 | Traditional | PDF ↗ |
| K900189 | CURAPULS 403 DIATHERMY UNIT | Henley Intl. | 1990-09-18 | Traditional | PDF ↗ |
| K895690 | ULTRA (THERAPEUTIC ULTRASOUND DEVICE) | Excel Tech. , Ltd. | 1990-02-20 | Traditional | PDF ↗ |
| K883893 | OMNISOUND(TM) 3000 | Physio Technology, Inc. | 1988-11-01 | Traditional | PDF ↗ |
| K872909 | SIEMENS SONODYNATOR 834, ULTRASOUND/STIMULATION | Elmed, Inc. | 1988-01-13 | Traditional | PDF ↗ |
| K872394 | SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT | Henley Intl. | 1987-09-03 | Traditional | PDF ↗ |
| K871647 | STIMULATOR, ULTRASOUND AND MUSCLE | Amy West | 1987-06-29 | Traditional | PDF ↗ |
| K861837 | FISCHER/KRYSTAL THERAPEUTIC ULTRASOUND | Fischer Industries, Inc. | 1986-08-07 | Traditional | PDF ↗ |
| K844217 | RICH-MAR DELTA 330 HV | Rich-Mar Corp. | 1984-11-27 | Traditional | PDF ↗ |
| K843351 | OMNISTIM II COMBIN. THERAPY SYS | Physio Technology, Inc. | 1984-09-18 | Traditional | PDF ↗ |
| K813594 | INTELECT MODEL 700 | Chattanooga Group, Inc. | 1982-02-22 | Traditional | PDF ↗ |
| K810526 | RICH-MAR HV II SELECT-A-PULSE | Rich-Mar Corp. | 1981-04-03 | Traditional | PDF ↗ |
| K772287 | MUSCLE STIMULATOR | Rich-Mar Corp. | 1978-01-13 | Traditional | PDF ↗ |
| K771157 | RM VI-HV | Rich-Mar Corp. | 1977-07-21 | Traditional | PDF ↗ |
Product code IMG · Class II · Physical Medicine. Data: openFDA.