Product Code: IMI FDA class 2 21 CFR 890.5300

Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

Physical Medicine

Ultrasonic Diathermy for Applying Therapeutic Deep Heat is a Physical Medicine device that uses ultrasonic energy to generate deep tissue heating within muscles and joints, used to relieve pain, reduce muscle spasm, increase tissue extensibility, and promote healing of soft tissue injuries. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is IMI, regulated under 21 CFR 890.5300, within the Physical Medicine medical specialty. This device is eligible for third party review, meaning the 510(k) submission may be reviewed by an FDA-accredited third party organization.

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FEI Numbers

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Basic Information

Product Code: IMI
Device Class: FDA class 2
Regulation Number: 890.5300
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 89 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K240788	Ultrasound Stimulator	Jun 04, 2025	Substantially Equivalent	Jkh Health Co., Ltd.
K230472	Sonopuls 190	Oct 24, 2023	Substantially Equivalent	Enraf-Nonius, B.V.
K222098	ManaSport+	Mar 08, 2023	Substantially Equivalent	Manamed, Inc.
K210284	ManaSport	Apr 26, 2022	Substantially Equivalent	Manamed, Inc.
K202788	Sonomed IV, Sonomed V	Dec 23, 2021	Substantially Equivalent	Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto
K160378	BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)	Aug 25, 2017	Substantially Equivalent	Brh Medical , Ltd.
K161628	JAS Pulse(TM) Ultrasonic Therapy	Nov 10, 2016	Substantially Equivalent	Bonutti Research, Inc.
K160075	Accent XL	Aug 17, 2016	Substantially Equivalent	Alma Lasers, Inc.
K161502	MC1 Plus	Aug 16, 2016	Substantially Equivalent	General Project S.R.L.
K142976	UltraTENS	Aug 26, 2015	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.
K131309	SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ	Jan 27, 2014	Substantially Equivalent	Ibramed Equipamentos Medicos
K130888	SONOPULSE/ SONOPULSE III	Jan 09, 2014	Substantially Equivalent	Ibramed- Industria Brazileria DE Equipamentos Medi
K124010	ACCUSONIC ADVANTAGE	Aug 23, 2013	Substantially Equivalent	Metron Medical Australia, Pty, Ltd.
K120171	ACCUSONIC ADVANTAGE	May 04, 2012	Substantially Equivalent	Metron Medical Australia, Pty, Ltd.
K112520	US-101L, US-103S	Oct 26, 2011	Substantially Equivalent	Ito Co., Ltd.
K091615	MED CONTOUR	May 06, 2010	Substantially Equivalent	General Project S.R.L.
K090542	SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900	Oct 23, 2009	Substantially Equivalent	Sun-Rain System Corp.
K062256	HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM	Feb 26, 2007	Substantially Equivalent	Hill Laboratories Co.
K053041	MED SCULPT	Aug 02, 2006	Substantially Equivalent	General Project S.R.L.
K052934	DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM	Jun 12, 2006	Substantially Equivalent	S.O.R. Internacional, S.A.
K053546	SONICATOR 740, MODEL ME 740	May 04, 2006	Substantially Equivalent	Mettler Electronics Corp.
K050410	HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)	Jul 14, 2005	Substantially Equivalent	Hwang Sun Enterprise Co., Ltd.
K040798	HES ULTRASONIC THERAPY APPLIANCE	Aug 04, 2004	Substantially Equivalent	Hwang Sun Enterprise Co., Ltd.
K031116	VECTRA (INTELECT) EPR ULTRASOUND	Dec 03, 2003	Substantially Equivalent	Chattanooga Group
K024013	SUN-RAIN ULTRASONIC THERAPY, SU-100	Oct 31, 2003	Substantially Equivalent	Sun-Rain System Corp.
K031329	DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY)	Oct 22, 2003	Substantially Equivalent	Dynatronics Corp.
K032793	US-100 PORTABLE ULTRASOUND THERAPY UNIT	Oct 09, 2003	Substantially Equivalent	Ito Co., Ltd.
K024307	DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM	Jul 02, 2003	Substantially Equivalent	Sybaritic, Inc.
K030878	ACCOUSONIC, MODEL AS-270	Mar 28, 2003	Substantially Equivalent	Metron Medical Australia, Pty, Ltd.
K030410	ACCOUSONIC PLUS, MODEL AP-170	Feb 20, 2003	Substantially Equivalent	Metron Medical Australia, Pty, Ltd.
K021483	RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND	Sep 13, 2002	Substantially Equivalent	Rich-Mar Corp.
K013192	SONICATOR PLUS 930, MODEL ME 930	Oct 17, 2001	Substantially Equivalent	Mettler Electronics Corp.
K010702	XUB EXTERNAL ULTRASOUND	Aug 09, 2001	Substantially Equivalent	Kmi Kolster Methods, Inc.
K011955	MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100	Jul 16, 2001	Substantially Equivalent	Metron Medical Australia, Pty, Ltd.
K010609	ACCUSONIC, MODEL AS-260	Mar 16, 2001	Substantially Equivalent	Metron Medical Australia, Pty, Ltd.
K010102	SONIC MODEL SO-300	Feb 09, 2001	Substantially Equivalent	Metron Medical Australia, Pty, Ltd.
K991613	SW ULTRASOUND, MODELS 331, 311, 333	Dec 08, 2000	Substantially Equivalent	Starbene
K000593	SONIC, MODEL SO-100	Aug 04, 2000	Substantially Equivalent	Metron Medical Australia, Pty, Ltd.
K000084	ENRAF-NONIUS SONOPULS 190 SYSTEM	Aug 04, 2000	Substantially Equivalent	Henley Healthcare, Inc.
K001370	ACCUSONIC PLUS, MODEL AP-100	Jul 17, 2000	Substantially Equivalent	Metron Medical Australia, Pty, Ltd.
K000604	NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT	May 23, 2000	Substantially Equivalent	Naturopathic Laboratories International, Inc.
K984199	EXONIX	Feb 17, 1999	Substantially Equivalent	Fibra Sonics, Inc.
K981449	SD-956 ULTRASOUND THERAPY	Dec 11, 1998	Substantially Equivalent	Skylark Device Co., Ltd.
K982544	RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES	Nov 19, 1998	Substantially Equivalent	Rich-Mar Corp.
K982829	FORTE, MODEL CPS ULTRASOUND	Nov 06, 1998	Substantially Equivalent	Chattanooga Group, Inc.
K973024	INTELECT LEGEND ULTRASOUND	Nov 10, 1997	Substantially Equivalent	Chattanooga Group, Inc.
K970131	ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE	Jun 16, 1997	Substantially Equivalent	C.L. Mcintosh & Assoc., Inc.
K961250	DYNATRON 125 ULTRASOUND	Aug 26, 1996	Substantially Equivalent	Dynatronics Corp.
K960802	CUSHMAN MANUFACTURING, INC. ULTRA 6.0.	Jun 18, 1996	Substantially Equivalent	Cushman Mfg., Inc.
K954136	MATRIX MICROSON 410	Apr 01, 1996	Substantially Equivalent	Matrix Biokinetics, Inc.
K952536	SONO 5	Mar 05, 1996	Substantially Equivalent for Some Indications	Zimmer Elektromedizin GmbH
K944596	GRAHAM-FIELD ULTRASOUND LOTION	Jun 07, 1995	Substantially Equivalent	Chester Labs, Inc.
K950564	RICH-MAR US-II ULTRASOUND	May 15, 1995	Substantially Equivalent	Rich-Mar Corp.
K930307	INTELECT 222 P	Jul 02, 1993	Substantially Equivalent	Chattanooga Group, Inc.
K930186	INTERTRON 6000/6100	Jul 02, 1993	Substantially Equivalent	Williams Healthcare Systems, LLC
K922839	MID-CANADA MEDICAL	Jul 02, 1993	Substantially Equivalent	Mid-Canada Medical
K923076	ULTRA SX	Mar 09, 1993	Substantially Equivalent	Excel Tech. , Ltd.
K920983	SONOPULS 590	Mar 09, 1993	Substantially Equivalent	Henley Intl.
K915557	RICH-MAR MODEL 510 ULTRASOUND	Mar 10, 1992	Substantially Equivalent	Rich-Mar Corp.
K913981	RICH-MAR MODEL II ULTRASOUND	Nov 13, 1991	Substantially Equivalent	Rich-Mar Corp.
K912202	RICH-MAR MODEL 25 ULTRASOUND	Sep 17, 1991	Substantially Equivalent	Rich-Mar Corp.
K910708	RICH-MAR MODEL X ULTRASOUND THERAPY DEVICE	May 21, 1991	Substantially Equivalent	Rich-Mar Corp.
K904051	RICH-MAR MODEL V ULTRASOUND	Jan 14, 1991	Substantially Equivalent	Rich-Mar Corp.
K901950	DITER ULTRASONIC S 3000	Jul 27, 1990	Substantially Equivalent	Diter Elektroniikka OY
K894152	MEDITHERM	Jun 11, 1990	Substantially Equivalent	Medical Equipment Designs, Inc.
K883228	SONICATOR 720 (MODEL ME720)	Aug 18, 1988	Substantially Equivalent	Mettler Electronics Corp.
K881211	TRU-TECH 310 ULTRASOUND THERAPY UNIT #310	May 11, 1988	Substantially Equivalent	Tru-Trac Therapy Products, Inc.
K875381	ULTRASOUND DIATHERMY UNIT ULTRASOUND HEATER	May 03, 1988	Substantially Equivalent	Ford Laboratories, Inc.
K880901	SONICATOR 710 (MODEL ME710)	Mar 17, 1988	Substantially Equivalent	Mettler Electronics Corp.
K880602	MODIFIED SONICATOR 720, MODEL ME720	Feb 25, 1988	Substantially Equivalent	Mettler Electronics Corp.
K873812	SONICATOR 720 (MODEL ME720)	Dec 10, 1987	Substantially Equivalent	Mettler Electronics Corp.
K872393	SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT	Jul 23, 1987	Substantially Equivalent	Henley Intl.
K860099	MEDCO-SONIC NQ-2000	Apr 09, 1986	Substantially Equivalent	Medco Products, Co., Inc.
K851937	SONOMED 4	Jul 17, 1985	Substantially Equivalent	Robert Bosch Corp.
K851397	SONICATOR 705 MODEL ME 705	Jul 02, 1985	Substantially Equivalent	Mettler Electronics Corp.
K850640	SONOPULS 434 ULTRASOUND THERAPY EQUIPMENT	May 14, 1985	Substantially Equivalent	Fluidotherapy Corp.
K844386	ESCOTEK-EST 301A ULTRA-SONIC UNIT	May 01, 1985	Substantially Equivalent	Nor-Am Patient Care Products, Inc.
K844036	US 610	Nov 27, 1984	Substantially Equivalent	Rich-Mar Corp.
K843372	OMNISOUND THERAPY UNIT	Sep 18, 1984	Substantially Equivalent	Physio Technology, Inc.
K843221	MEGASON MODEL 150	Aug 24, 1984	Substantially Equivalent	Birtcher Corp.
K841447	INTELECT 210 PORTABLE ULTRASOUND	May 09, 1984	Substantially Equivalent	Chattanooga Group, Inc.
K841446	INTELECT 200 THERAPEUTIC ULTRASOUND	May 09, 1984	Substantially Equivalent	Chattanooga Group, Inc.
K841445	INTELECT 205 PORTABLE ULTRASOUND UNIT	May 09, 1984	Substantially Equivalent	Chattanooga Group, Inc.
K813593	INTELECT MODEL 200	Feb 22, 1982	Substantially Equivalent	Chattanooga Group, Inc.
K812752	MICRO MED INT'L MICRO SOUND US-100	Jan 19, 1982	Substantially Equivalent	N-Tron Electronics
K811159	DYNASOUND 801	May 27, 1981	Substantially Equivalent	Dynawave, Corp.
K800632	MODEL 118 PULSE MEGASON	May 02, 1980	Substantially Equivalent	Birtcher Corp.
K791976	DYNASOUND 601	Jan 09, 1980	Substantially Equivalent	Dynawave, Corp.
K781317	ULTRASONIC THERAPY APPARATUS, 407	Oct 03, 1978	Substantially Equivalent	General Theraphysical, Inc.