Atlas FDA

IMI

89 FDA 510(k) clearances · Product code

121 daysmedian time to decision
337 days90th percentile
89clearances measured

FDA profile

Official device name
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5300
Medical specialty
Physical Medicine
Flags
Third-party review eligible
Adverse events (MAUDE)
1992: 1 · 1999: 3 · 2001: 7 · 2011: 9
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Ultrasound Stimulator (K240788)Jkh Health Co., Ltd.2025-06-04
Sonopuls 190 (K230472)Enraf-Nonius, B.V.2023-10-24
ManaSport+ (K222098)Manamed, Inc.2023-03-08
ManaSport (K210284)Manamed, Inc.2022-04-26
Sonomed IV, Sonomed V (K202788)Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto2021-12-23
BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) (K160378)Brh Medical , Ltd.2017-08-25
JAS Pulse(TM) Ultrasonic Therapy (K161628)Bonutti Research, Inc.2016-11-10
Accent XL (K160075)Alma Lasers, Inc.2016-08-17
MC1 Plus (K161502)General Project S.R.L.2016-08-16
UltraTENS (K142976)Shenzhen Dongdixin Technology Co., Ltd.2015-08-26
SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ (K131309)Ibramed Equipamentos Medicos2014-01-27
SONOPULSE/ SONOPULSE III (K130888)Ibramed- Industria Brazileria DE Equipamentos Medi2014-01-09
ACCUSONIC ADVANTAGE (K124010)Metron Medical Australia, Pty, Ltd.2013-08-23
ACCUSONIC ADVANTAGE (K120171)Metron Medical Australia, Pty, Ltd.2012-05-04
US-101L, US-103S (K112520)Ito Co., Ltd.2011-10-26
MED CONTOUR (K091615)General Project S.R.L.2010-05-06
SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900 (K090542)Sun-Rain System Corp.2009-10-23
HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM (K062256)Hill Laboratories Co.2007-02-26
MED SCULPT (K053041)General Project S.R.L.2006-08-02
DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM (K052934)S.O.R. Internacional, S.A.2006-06-12
SONICATOR 740, MODEL ME 740 (K053546)Mettler Electronics Corp.2006-05-04
HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ) (K050410)Hwang Sun Enterprise Co., Ltd.2005-07-14
HES ULTRASONIC THERAPY APPLIANCE (K040798)Hwang Sun Enterprise Co., Ltd.2004-08-04
VECTRA (INTELECT) EPR ULTRASOUND (K031116)Chattanooga Group2003-12-03
SUN-RAIN ULTRASONIC THERAPY, SU-100 (K024013)Sun-Rain System Corp.2003-10-31
DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY) (K031329)Dynatronics Corp.2003-10-22
US-100 PORTABLE ULTRASOUND THERAPY UNIT (K032793)Ito Co., Ltd.2003-10-09
DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM (K024307)Sybaritic, Inc.2003-07-02
ACCOUSONIC, MODEL AS-270 (K030878)Metron Medical Australia, Pty, Ltd.2003-03-28
ACCOUSONIC PLUS, MODEL AP-170 (K030410)Metron Medical Australia, Pty, Ltd.2003-02-20
RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND (K021483)Rich-Mar Corp.2002-09-13
SONICATOR PLUS 930, MODEL ME 930 (K013192)Mettler Electronics Corp.2001-10-17
XUB EXTERNAL ULTRASOUND (K010702)Kmi Kolster Methods, Inc.2001-08-09
MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 (K011955)Metron Medical Australia, Pty, Ltd.2001-07-16
ACCUSONIC, MODEL AS-260 (K010609)Metron Medical Australia, Pty, Ltd.2001-03-16
SONIC MODEL SO-300 (K010102)Metron Medical Australia, Pty, Ltd.2001-02-09
SW ULTRASOUND, MODELS 331, 311, 333 (K991613)Starbene2000-12-08
ENRAF-NONIUS SONOPULS 190 SYSTEM (K000084)Henley Healthcare, Inc.2000-08-04
SONIC, MODEL SO-100 (K000593)Metron Medical Australia, Pty, Ltd.2000-08-04
ACCUSONIC PLUS, MODEL AP-100 (K001370)Metron Medical Australia, Pty, Ltd.2000-07-17
NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT (K000604)Naturopathic Laboratories International, Inc.2000-05-23
EXONIX (K984199)Fibra Sonics, Inc.1999-02-17
SD-956 ULTRASOUND THERAPY (K981449)Skylark Device Co., Ltd.1998-12-11
RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES (K982544)Rich-Mar Corp.1998-11-19
FORTE, MODEL CPS ULTRASOUND (K982829)Chattanooga Group, Inc.1998-11-06
INTELECT LEGEND ULTRASOUND (K973024)Chattanooga Group, Inc.1997-11-10
ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE (K970131)C.L. Mcintosh & Assoc., Inc.1997-06-16
DYNATRON 125 ULTRASOUND (K961250)Dynatronics Corp.1996-08-26
CUSHMAN MANUFACTURING, INC. ULTRA 6.0. (K960802)Cushman Mfg., Inc.1996-06-18
MATRIX MICROSON 410 (K954136)Matrix Biokinetics, Inc.1996-04-01
SONO 5 (K952536)Zimmer Elektromedizin GmbH1996-03-05
GRAHAM-FIELD ULTRASOUND LOTION (K944596)Chester Labs, Inc.1995-06-07
RICH-MAR US-II ULTRASOUND (K950564)Rich-Mar Corp.1995-05-15
INTELECT 222 P (K930307)Chattanooga Group, Inc.1993-07-02
INTERTRON 6000/6100 (K930186)Williams Healthcare Systems, LLC1993-07-02
MID-CANADA MEDICAL (K922839)Mid-Canada Medical1993-07-02
SONOPULS 590 (K920983)Henley Intl.1993-03-09
ULTRA SX (K923076)Excel Tech. , Ltd.1993-03-09
RICH-MAR MODEL 510 ULTRASOUND (K915557)Rich-Mar Corp.1992-03-10
RICH-MAR MODEL II ULTRASOUND (K913981)Rich-Mar Corp.1991-11-13
RICH-MAR MODEL 25 ULTRASOUND (K912202)Rich-Mar Corp.1991-09-17
RICH-MAR MODEL X ULTRASOUND THERAPY DEVICE (K910708)Rich-Mar Corp.1991-05-21
RICH-MAR MODEL V ULTRASOUND (K904051)Rich-Mar Corp.1991-01-14
DITER ULTRASONIC S 3000 (K901950)Diter Elektroniikka OY1990-07-27
MEDITHERM (K894152)Medical Equipment Designs, Inc.1990-06-11
SONICATOR 720 (MODEL ME720) (K883228)Mettler Electronics Corp.1988-08-18
TRU-TECH 310 ULTRASOUND THERAPY UNIT #310 (K881211)Tru-Trac Therapy Products, Inc.1988-05-11
ULTRASOUND DIATHERMY UNIT ULTRASOUND HEATER (K875381)Ford Laboratories, Inc.1988-05-03
SONICATOR 710 (MODEL ME710) (K880901)Mettler Electronics Corp.1988-03-17
MODIFIED SONICATOR 720, MODEL ME720 (K880602)Mettler Electronics Corp.1988-02-25
SONICATOR 720 (MODEL ME720) (K873812)Mettler Electronics Corp.1987-12-10
SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT (K872393)Henley Intl.1987-07-23
MEDCO-SONIC NQ-2000 (K860099)Medco Products, Co., Inc.1986-04-09
SONOMED 4 (K851937)Robert Bosch Corp.1985-07-17
SONICATOR 705 MODEL ME 705 (K851397)Mettler Electronics Corp.1985-07-02
SONOPULS 434 ULTRASOUND THERAPY EQUIPMENT (K850640)Fluidotherapy Corp.1985-05-14
ESCOTEK-EST 301A ULTRA-SONIC UNIT (K844386)Nor-Am Patient Care Products, Inc.1985-05-01
US 610 (K844036)Rich-Mar Corp.1984-11-27
OMNISOUND THERAPY UNIT (K843372)Physio Technology, Inc.1984-09-18
MEGASON MODEL 150 (K843221)Birtcher Corp.1984-08-24
INTELECT 210 PORTABLE ULTRASOUND (K841447)Chattanooga Group, Inc.1984-05-09
INTELECT 200 THERAPEUTIC ULTRASOUND (K841446)Chattanooga Group, Inc.1984-05-09
INTELECT 205 PORTABLE ULTRASOUND UNIT (K841445)Chattanooga Group, Inc.1984-05-09
INTELECT MODEL 200 (K813593)Chattanooga Group, Inc.1982-02-22
MICRO MED INT'L MICRO SOUND US-100 (K812752)N-Tron Electronics1982-01-19
DYNASOUND 801 (K811159)Dynawave, Corp.1981-05-27
MODEL 118 PULSE MEGASON (K800632)Birtcher Corp.1980-05-02
DYNASOUND 601 (K791976)Dynawave, Corp.1980-01-09
ULTRASONIC THERAPY APPARATUS, 407 (K781317)General Theraphysical, Inc.1978-10-03

Track IMI automatically

Every clearance here is in the API, with alerts when new ones post.