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 |