FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K160075 |
Alma Lasers Inc. |
Accent XL |
08/17/2016 |
K161628 |
Bonutti Research, Inc. |
JAS Pulse(TM) Ultrasonic Therapy |
11/10/2016 |
K160378 |
BRH Medical Ltd. |
BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) |
08/25/2017 |
K970131 |
C.L. MCINTOSH & ASSOC., INC. |
ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE |
06/16/1997 |
K202788 |
Carci Industria E Comercio De Aparelhos Cirurgicos E Orto |
Sonomed IV, Sonomed V |
12/23/2021 |
K031116 |
CHATTANOOGA GROUP |
VECTRA (INTELECT) EPR ULTRASOUND |
12/03/2003 |
K982829 |
CHATTANOOGA GROUP, INC. |
FORTE, MODEL CPS ULTRASOUND |
11/06/1998 |
K973024 |
CHATTANOOGA GROUP, INC. |
INTELECT LEGEND ULTRASOUND |
11/10/1997 |
K960802 |
CUSHMAN MFG., INC. |
CUSHMAN MANUFACTURING, INC. ULTRA 6.0. |
06/18/1996 |
K961250 |
DYNATRONICS CORP. |
DYNATRON 125 ULTRASOUND |
08/26/1996 |
K031329 |
DYNATRONICS CORP. |
DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY) |
10/22/2003 |
K984199 |
FIBRA SONICS, INC. |
EXONIX |
02/17/1999 |
K161502 |
GENERAL PROJECT S.R.L. |
MC1 Plus |
08/16/2016 |
K091615 |
GENERAL PROJECT S.R.L. |
MED CONTOUR |
05/06/2010 |
K053041 |
GENERAL PROJECT S.R.L. |
MED SCULPT |
08/02/2006 |
K000084 |
HENLEY HEALTHCARE, INC. |
ENRAF-NONIUS SONOPULS 190 SYSTEM |
08/04/2000 |
K062256 |
HILL LABORATORIES CO. |
HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM |
02/26/2007 |
K040798 |
HWANG SUN ENTERPRISE CO., LTD. |
HES ULTRASONIC THERAPY APPLIANCE |
08/04/2004 |
K050410 |
HWANG SUN ENTERPRISE CO., LTD. |
HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ) |
07/14/2005 |
K131309 |
IBRAMED EQUIPAMENTOS MEDICOS |
SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ |
01/27/2014 |
K130888 |
IBRAMED- INDUSTRIA BRAZILERIA DE EQUIPAMENTOS MEDI |
SONOPULSE/ SONOPULSE III |
01/09/2014 |
K032793 |
ITO CO., LTD. |
US-100 PORTABLE ULTRASOUND THERAPY UNIT |
10/09/2003 |
K112520 |
ITO CO., LTD. |
US-101L, US-103S |
10/26/2011 |
K010702 |
KMI KOLSTER METHODS, INC. |
XUB EXTERNAL ULTRASOUND |
08/09/2001 |
K210284 |
ManaMed, Inc. |
ManaSport |
04/26/2022 |
K222098 |
ManaMed, Inc. |
ManaSport+ |
03/08/2023 |
K954136 |
MATRIX BIOKINETICS, INC. |
MATRIX MICROSON 410 |
04/01/1996 |
K030410 |
METRON MEDICAL AUSTRALIA PTY LTD |
ACCOUSONIC PLUS, MODEL AP-170 |
02/20/2003 |
K120171 |
METRON MEDICAL AUSTRALIA PTY LTD |
ACCUSONIC ADVANTAGE |
05/04/2012 |
K124010 |
METRON MEDICAL AUSTRALIA PTY LTD |
ACCUSONIC ADVANTAGE |
08/23/2013 |
K001370 |
METRON MEDICAL AUSTRALIA PTY LTD |
ACCUSONIC PLUS, MODEL AP-100 |
07/17/2000 |
K010609 |
METRON MEDICAL AUSTRALIA PTY LTD |
ACCUSONIC, MODEL AS-260 |
03/16/2001 |
K011955 |
METRON MEDICAL AUSTRALIA PTY LTD |
MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 |
07/16/2001 |
K010102 |
METRON MEDICAL AUSTRALIA PTY LTD |
SONIC MODEL SO-300 |
02/09/2001 |
K000593 |
METRON MEDICAL AUSTRALIA PTY LTD |
SONIC, MODEL SO-100 |
08/04/2000 |
K030878 |
METRON MEDICAL AUSTRALIA, PTY, LTD. |
ACCOUSONIC, MODEL AS-270 |
03/28/2003 |
K053546 |
METTLER ELECTRONICS CORP. |
SONICATOR 740, MODEL ME 740 |
05/04/2006 |
K013192 |
METTLER ELECTRONICS CORP. |
SONICATOR PLUS 930, MODEL ME 930 |
10/17/2001 |
K000604 |
NATUROPATHIC LABORATORIES INTERNATIONAL, INC. |
NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT |
05/23/2000 |
K021483 |
RICH-MAR CORP. |
RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND |
09/13/2002 |
K982544 |
RICH-MAR CORP. |
RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES |
11/19/1998 |
K052934 |
S.O.R. INTERNACIONAL, S.A. |
DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM |
06/12/2006 |
K142976 |
Shenzhen Dongdixin Technology Co., Ltd |
UltraTENS |
08/26/2015 |
K981449 |
SKYLARK DEVICE CO., LTD. |
SD-956 ULTRASOUND THERAPY |
12/11/1998 |
K991613 |
STARBENE |
SW ULTRASOUND, MODELS 331, 311, 333 |
12/08/2000 |
K090542 |
SUN-RAIN SYSTEM CORP. |
SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900 |
10/23/2009 |
K024013 |
SUN-RAIN SYSTEM CORP. |
SUN-RAIN ULTRASONIC THERAPY, SU-100 |
10/31/2003 |
K024307 |
SYBARITIC, INC. |
DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM |
07/02/2003 |
K952536 |
ZIMMER ELEKTROMEDIZIN GMBH |
SONO 5 |
03/05/1996 |