Panels › Physical Medicine › Product code IMG · Class 2
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Regulation 890.5860
0510(k)s in 12 months (55 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in IMG
| Company | 510(k)s | Recalls |
|---|---|---|
| Chattanooga Group | 13 | 0 |
| Mettler Electronics Corp. | 6 | 0 |
| Rich-Mar Corp. | 5 | 0 |
| Excel Tech. , Ltd. | 3 | 0 |
| Henley Intl. | 3 | 0 |
| Shenzhen Dongdixin Technology Co., Ltd. | 3 | 0 |
| Alfa Tech Medical Systems, Ltd. | 2 | 0 |
| Chattanooga Corp Inc | 0 | 2 |
| Dynatronics Corp. | 2 | 0 |
| Metron Medical Australia, Pty, Ltd. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 7, 2025 | K244041 | Ultrasound Therapy Workstation (XMS-UET2) Xemis Medical Technology (Shenzhen) Co., Ltd., CN | IMG |
| Aug 26, 2016 | K153559 | OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System Accelerated Care Plus (Acp) | IMG |
| Nov 13, 2015 | K150436 | ComboRehab Shenzhen Dongdixin Technology Co., Ltd., CN | IMG |
| Nov 13, 2015 | K150353 | BTL-4000 BTL Industries, Inc. | IMG |
| Nov 21, 2012 | K120217 | SONICSTIMU COMBO THERAPEUTIC DEVICE Shenzhen Dongdixin Technology Co., Ltd., CN | IMG |
| Aug 7, 2012 | K121059 | SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM Zimmer Medizinsystems GmbH, DE | IMG |
| Nov 3, 2011 | K102524 | FUTURA Dr. Oliver Wenker, M.D., M.B.A. | IMG |
| Aug 25, 2011 | K111482 | SONICATOR PLUS 920 Mettler Electronics Corp. | IMG |
| Mar 17, 2011 | K102190 | WINSTIM Johari Digital Healthcare , Ltd., IN | IMG |
| Jan 14, 2010 | K092627 | CT2011 SONICSTIMU PAIN RELIEF DEVICE Shenzhen Dongdixin Technology Co., Ltd., CN | IMG |
| Aug 1, 2007 | K071137 | SONICATOR PLUS 940, MODEL ME940 Mettler Electronics Corp. | IMG |
| Apr 4, 2007 | K063728 | TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM Alfa Tech Medical Systems, Ltd. | IMG |
| Feb 5, 2007 | K063135 | SONIC-STIM Naimco, Inc. | IMG |
| Dec 9, 2005 | K052340 | DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM Alfa Tech Medical Systems, Ltd. | IMG |
| Apr 12, 2004 | K040285 | VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER Chattanooga Group | IMG |
| Mar 17, 2004 | K040121 | DERMAWAVE 5000 COMBI MAX SYSTEM Dermawave, LLC | IMG |
| Dec 11, 2003 | K031077 | VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM Chattanooga Group | IMG |
| Apr 18, 2003 | K030880 | VECTORSONIC, MODEL VU-270 Metron Medical Australia, Pty, Ltd., AU | IMG |
| Feb 14, 2003 | K023050 | RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI Reliant Technologies, Inc. | IMG |
| Jul 22, 2002 | K020119 | VECTORSONIC, MODEL VU-200 Metron Medical Australia, Pty, Ltd., AU | IMG |
| Jul 7, 2000 | K001166 | ULTRA V THERAPEUTIC ULTRASOUND Excel Tech. , Ltd., CA | IMG |
| Feb 1, 1999 | K982317 | VECTRA COMBO Chattanooga Group, Inc. | IMG |
| Nov 6, 1998 | K982830 | FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO Chattanooga Group, Inc. | IMG |
| Oct 27, 1995 | K953614 | FORTE Chattanooga Group, Inc. | IMG |
| Jun 21, 1995 | K951746 | FORTE CB Chattanooga Group, Inc. | IMG |
| Aug 29, 1994 | K943469 | SONICATOR 730 Mettler Electronics Corp. | IMG |
| Jun 20, 1994 | K941561 | FORTE US Chattanooga Group, Inc. | IMG |
| Apr 26, 1994 | K935728 | DYNATRON 150 Dynatronics Corp. | IMG |
| Apr 15, 1994 | K940180 | FORTE US Chattanooga Group, Inc. | IMG |
| Apr 4, 1994 | K934287 | DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR Dynawave, Corp. | IMG |
| Mar 23, 1994 | K934846 | SONICATOR 716 Mettler Electronics Corp. | IMG |
| Feb 2, 1994 | K935271 | THERAPEUTIC ULTRASOUND AND STIMULATOR Chattanooga Group, Inc. | IMG |
| Jan 21, 1994 | K934845 | SONICATOR 715 Mettler Electronics Corp. | IMG |
| Oct 8, 1993 | K932937 | DYNATRON 800 Dynatronics Corp. | IMG |
| Jun 29, 1993 | K922036 | SONOPULS 591 Henley Intl. | IMG |
| Apr 27, 1993 | K921436 | SONICATOR PLUS Mettler Electronics Corp. | IMG |
| Mar 9, 1993 | K921952 | ULTRA III Excel Tech. , Ltd., CA | IMG |
| Mar 4, 1993 | K920939 | DYNATRON 300 ULRASOUND Dynatronics Laser Corp. | IMG |
| Nov 6, 1992 | K923797 | MODEL 25 THERAPEUTIC ULTRASOUND -- MODIFIED Rich-Mar Corp. | IMG |
| Dec 17, 1991 | K911733 | INTELECT, MODEL 245 Chattanooga Group, Inc. | IMG |
| Sep 27, 1990 | K902875 | INTELECT 750 MP Chattanooga Group, Inc. | IMG |
| Sep 27, 1990 | K902860 | INTELECT 170 Chattanooga Group, Inc. | IMG |
| Sep 18, 1990 | K900189 | CURAPULS 403 DIATHERMY UNIT Henley Intl. | IMG |
| Feb 20, 1990 | K895690 | ULTRA (THERAPEUTIC ULTRASOUND DEVICE) Excel Tech. , Ltd., CA | IMG |
| Nov 1, 1988 | K883893 | OMNISOUND(TM) 3000 Physio Technology, Inc. | IMG |
| Jan 13, 1988 | K872909 | SIEMENS SONODYNATOR 834, ULTRASOUND/STIMULATION Elmed, Inc. | IMG |
| Sep 3, 1987 | K872394 | SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT Henley Intl. | IMG |
| Jun 29, 1987 | K871647 | STIMULATOR, ULTRASOUND AND MUSCLE Amy West | IMG |
| Aug 7, 1986 | K861837 | FISCHER/KRYSTAL THERAPEUTIC ULTRASOUND Fischer Industries, Inc. | IMG |
| Nov 27, 1984 | K844217 | RICH-MAR DELTA 330 HV Rich-Mar Corp. | IMG |
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