Panels › Physical Medicine › Product code IMI · Class 2
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Regulation 890.5300
0510(k)s in 12 months (89 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in IMI
| Company | 510(k)s | Recalls |
|---|---|---|
| Metron Medical Australia, Pty, Ltd. | 9 | 0 |
| Rich-Mar Corp. | 9 | 0 |
| Chattanooga Group | 8 | 0 |
| Mettler Electronics Corp. | 7 | 0 |
| General Project S.R.L. | 3 | 0 |
| Birtcher Corp. | 2 | 0 |
| Chattanooga Corp Inc | 0 | 2 |
| Dynatronics Corp. | 2 | 0 |
| Dynawave, Corp. | 2 | 0 |
| Henley Intl. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 4, 2025 | K240788 | Ultrasound Stimulator Jkh Health Co., Ltd., CN | IMI |
| Oct 24, 2023 | K230472 | Sonopuls 190 Enraf-Nonius, B.V., NL | IMI |
| Mar 8, 2023 | K222098 | ManaSport+ Manamed, Inc. | IMI |
| Apr 26, 2022 | K210284 | ManaSport Manamed, Inc. | IMI |
| Dec 23, 2021 | K202788 | Sonomed IV, Sonomed V Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto, BR | IMI |
| Aug 25, 2017 | K160378 | BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) Brh Medical , Ltd., IL | IMI |
| Nov 10, 2016 | K161628 | JAS Pulse(TM) Ultrasonic Therapy Bonutti Research, Inc. | IMI |
| Aug 17, 2016 | K160075 | Accent XL Alma Lasers, Inc. | IMI |
| Aug 16, 2016 | K161502 | MC1 Plus General Project S.R.L., IT | IMI |
| Aug 26, 2015 | K142976 | UltraTENS Shenzhen Dongdixin Technology Co., Ltd., CN | IMI |
| Jan 27, 2014 | K131309 | SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ Ibramed Equipamentos Medicos | IMI |
| Jan 9, 2014 | K130888 | SONOPULSE/ SONOPULSE III Ibramed- Industria Brazileria DE Equipamentos Medi | IMI |
| Aug 23, 2013 | K124010 | ACCUSONIC ADVANTAGE Metron Medical Australia, Pty, Ltd., AU | IMI |
| May 4, 2012 | K120171 | ACCUSONIC ADVANTAGE Metron Medical Australia, Pty, Ltd., AU | IMI |
| Oct 26, 2011 | K112520 | US-101L, US-103S Ito Co., Ltd., JP | IMI |
| May 6, 2010 | K091615 | MED CONTOUR General Project S.R.L. | IMI |
| Oct 23, 2009 | K090542 | SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900 Sun-Rain System Corp., TW | IMI |
| Feb 26, 2007 | K062256 | HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM Hill Laboratories Co. | IMI |
| Aug 2, 2006 | K053041 | MED SCULPT General Project S.R.L. | IMI |
| Jun 12, 2006 | K052934 | DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM S.O.R. Internacional, S.A. | IMI |
| May 4, 2006 | K053546 | SONICATOR 740, MODEL ME 740 Mettler Electronics Corp. | IMI |
| Jul 14, 2005 | K050410 | HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ) Hwang Sun Enterprise Co., Ltd. | IMI |
| Aug 4, 2004 | K040798 | HES ULTRASONIC THERAPY APPLIANCE Hwang Sun Enterprise Co., Ltd. | IMI |
| Dec 3, 2003 | K031116 | VECTRA (INTELECT) EPR ULTRASOUND Chattanooga Group | IMI |
| Oct 31, 2003 | K024013 | SUN-RAIN ULTRASONIC THERAPY, SU-100 Sun-Rain System Corp., TW | IMI |
| Oct 22, 2003 | K031329 | DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY) Dynatronics Corp. | IMI |
| Oct 9, 2003 | K032793 | US-100 PORTABLE ULTRASOUND THERAPY UNIT Ito Co., Ltd. | IMI |
| Jul 2, 2003 | K024307 | DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM Sybaritic, Inc. | IMI |
| Mar 28, 2003 | K030878 | ACCOUSONIC, MODEL AS-270 Metron Medical Australia, Pty, Ltd., AU | IMI |
| Feb 20, 2003 | K030410 | ACCOUSONIC PLUS, MODEL AP-170 Metron Medical Australia, Pty, Ltd., AU | IMI |
| Sep 13, 2002 | K021483 | RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND Rich-Mar Corp. | IMI |
| Oct 17, 2001 | K013192 | SONICATOR PLUS 930, MODEL ME 930 Mettler Electronics Corp. | IMI |
| Aug 9, 2001 | K010702 | XUB EXTERNAL ULTRASOUND Kmi Kolster Methods, Inc. | IMI |
| Jul 16, 2001 | K011955 | MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 Metron Medical Australia, Pty, Ltd., AU | IMI |
| Mar 16, 2001 | K010609 | ACCUSONIC, MODEL AS-260 Metron Medical Australia, Pty, Ltd., AU | IMI |
| Feb 9, 2001 | K010102 | SONIC MODEL SO-300 Metron Medical Australia, Pty, Ltd., AU | IMI |
| Dec 8, 2000 | K991613 | SW ULTRASOUND, MODELS 331, 311, 333 Starbene, AR | IMI |
| Aug 4, 2000 | K000593 | SONIC, MODEL SO-100 Metron Medical Australia, Pty, Ltd., AU | IMI |
| Aug 4, 2000 | K000084 | ENRAF-NONIUS SONOPULS 190 SYSTEM Henley Healthcare, Inc. | IMI |
| Jul 17, 2000 | K001370 | ACCUSONIC PLUS, MODEL AP-100 Metron Medical Australia, Pty, Ltd., AU | IMI |
| May 23, 2000 | K000604 | NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT Naturopathic Laboratories International, Inc. | IMI |
| Feb 17, 1999 | K984199 | EXONIX Fibra Sonics, Inc. | IMI |
| Dec 11, 1998 | K981449 | SD-956 ULTRASOUND THERAPY Skylark Device Co., Ltd., TW | IMI |
| Nov 19, 1998 | K982544 | RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES Rich-Mar Corp. | IMI |
| Nov 6, 1998 | K982829 | FORTE, MODEL CPS ULTRASOUND Chattanooga Group, Inc. | IMI |
| Nov 10, 1997 | K973024 | INTELECT LEGEND ULTRASOUND Chattanooga Group, Inc. | IMI |
| Jun 16, 1997 | K970131 | ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE C.L. Mcintosh & Assoc., Inc. | IMI |
| Aug 26, 1996 | K961250 | DYNATRON 125 ULTRASOUND Dynatronics Corp. | IMI |
| Jun 18, 1996 | K960802 | CUSHMAN MANUFACTURING, INC. ULTRA 6.0. Cushman Mfg., Inc. | IMI |
| Apr 1, 1996 | K954136 | MATRIX MICROSON 410 Matrix Biokinetics, Inc. | IMI |
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