FDA 510(k) Applications for Medical Device Product Code "IMG"
(Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat)

FDA 510(k) Number Applicant Device Name Decision Date
K153559 Accelerated Care Plus (ACP) OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System 08/26/2016
K052340 ALFA TECH MEDICAL SYSTEMS, LTD. DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM 12/09/2005
K063728 ALFA TECH MEDICAL SYSTEMS, LTD. TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM 04/04/2007
K150353 BTL INDUSTRIES, INC BTL-4000 11/13/2015
K031077 CHATTANOOGA GROUP VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM 12/11/2003
K040285 CHATTANOOGA GROUP VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER 04/12/2004
K982830 CHATTANOOGA GROUP, INC. FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO 11/06/1998
K982317 CHATTANOOGA GROUP, INC. VECTRA COMBO 02/01/1999
K040121 DERMAWAVE, LLC DERMAWAVE 5000 COMBI MAX SYSTEM 03/17/2004
K102524 DR. OLIVER WENKER, M.D., M.B.A. FUTURA 11/03/2011
K001166 EXCEL TECH. LTD. ULTRA V THERAPEUTIC ULTRASOUND 07/07/2000
K102190 JOHARI DIGITAL HEALTHCARE, LTD. WINSTIM 03/17/2011
K020119 METRON MEDICAL AUSTRALIA PTY LTD VECTORSONIC, MODEL VU-200 07/22/2002
K030880 METRON MEDICAL AUSTRALIA PTY LTD VECTORSONIC, MODEL VU-270 04/18/2003
K111482 METTLER ELECTRONICS CORP. SONICATOR PLUS 920 08/25/2011
K071137 METTLER ELECTRONICS CORP. SONICATOR PLUS 940, MODEL ME940 08/01/2007
K063135 NAIMCO, INC. SONIC-STIM 02/05/2007
K023050 RELIANT TECHNOLOGIES, INC. RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI 02/14/2003
K150436 SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. ComboRehab 11/13/2015
K092627 SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. CT2011 SONICSTIMU PAIN RELIEF DEVICE 01/14/2010
K120217 SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. SONICSTIMU COMBO THERAPEUTIC DEVICE 11/21/2012
K121059 ZIMMER MEDIZINSYSTEMS GMBH SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM 08/07/2012


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact