FDA 510(k) Applications for Medical Device Product Code "IMI"
(Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat)
| 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 |
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