Product Code: IMG FDA class 2 21 CFR 890.5860

Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

Physical Medicine

A Stimulator combining Ultrasound and Muscle functions for applying therapeutic deep heat is a Physical Medicine device that delivers both ultrasonic energy and neuromuscular electrical stimulation simultaneously, used to treat musculoskeletal pain, promote tissue healing, and increase deep tissue temperature. 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 IMG, regulated under 21 CFR 890.5860, 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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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: IMG
Device Class: FDA class 2
Regulation Number: 890.5860
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 55 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K244041	Ultrasound Therapy Workstation (XMS-UET2)	Oct 07, 2025	Substantially Equivalent	Xemis Medical Technology (Shenzhen) Co., Ltd.
K153559	OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System	Aug 26, 2016	Substantially Equivalent	Accelerated Care Plus (Acp)
K150436	ComboRehab	Nov 13, 2015	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.
K150353	BTL-4000	Nov 13, 2015	Substantially Equivalent	BTL Industries, Inc.
K120217	SONICSTIMU COMBO THERAPEUTIC DEVICE	Nov 21, 2012	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.
K121059	SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM	Aug 07, 2012	Substantially Equivalent	Zimmer Medizinsystems GmbH
K102524	FUTURA	Nov 03, 2011	Substantially Equivalent	Dr. Oliver Wenker, M.D., M.B.A.
K111482	SONICATOR PLUS 920	Aug 25, 2011	Substantially Equivalent	Mettler Electronics Corp.
K102190	WINSTIM	Mar 17, 2011	Substantially Equivalent	Johari Digital Healthcare , Ltd.
K092627	CT2011 SONICSTIMU PAIN RELIEF DEVICE	Jan 14, 2010	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.
K071137	SONICATOR PLUS 940, MODEL ME940	Aug 01, 2007	Substantially Equivalent	Mettler Electronics Corp.
K063728	TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM	Apr 04, 2007	Substantially Equivalent	Alfa Tech Medical Systems, Ltd.
K063135	SONIC-STIM	Feb 05, 2007	Substantially Equivalent	Naimco, Inc.
K052340	DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM	Dec 09, 2005	Substantially Equivalent	Alfa Tech Medical Systems, Ltd.
K040285	VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALER	Apr 12, 2004	Substantially Equivalent	Chattanooga Group
K040121	DERMAWAVE 5000 COMBI MAX SYSTEM	Mar 17, 2004	Substantially Equivalent	Dermawave, LLC
K031077	VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM	Dec 11, 2003	Substantially Equivalent	Chattanooga Group
K030880	VECTORSONIC, MODEL VU-270	Apr 18, 2003	Substantially Equivalent	Metron Medical Australia, Pty, Ltd.
K023050	RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI	Feb 14, 2003	Substantially Equivalent	Reliant Technologies, Inc.
K020119	VECTORSONIC, MODEL VU-200	Jul 22, 2002	Substantially Equivalent	Metron Medical Australia, Pty, Ltd.
K001166	ULTRA V THERAPEUTIC ULTRASOUND	Jul 07, 2000	Substantially Equivalent	Excel Tech. , Ltd.
K982317	VECTRA COMBO	Feb 01, 1999	Substantially Equivalent	Chattanooga Group, Inc.
K982830	FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO	Nov 06, 1998	Substantially Equivalent	Chattanooga Group, Inc.
K953614	FORTE	Oct 27, 1995	Substantially Equivalent for Some Indications	Chattanooga Group, Inc.
K951746	FORTE CB	Jun 21, 1995	Substantially Equivalent	Chattanooga Group, Inc.
K943469	SONICATOR 730	Aug 29, 1994	Substantially Equivalent	Mettler Electronics Corp.
K941561	FORTE US	Jun 20, 1994	Substantially Equivalent	Chattanooga Group, Inc.
K935728	DYNATRON 150	Apr 26, 1994	Substantially Equivalent	Dynatronics Corp.
K940180	FORTE US	Apr 15, 1994	Substantially Equivalent	Chattanooga Group, Inc.
K934287	DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR	Apr 04, 1994	Substantially Equivalent	Dynawave, Corp.
K934846	SONICATOR 716	Mar 23, 1994	Substantially Equivalent	Mettler Electronics Corp.
K935271	THERAPEUTIC ULTRASOUND AND STIMULATOR	Feb 02, 1994	Substantially Equivalent	Chattanooga Group, Inc.
K934845	SONICATOR 715	Jan 21, 1994	Substantially Equivalent	Mettler Electronics Corp.
K932937	DYNATRON 800	Oct 08, 1993	Substantially Equivalent	Dynatronics Corp.
K922036	SONOPULS 591	Jun 29, 1993	Substantially Equivalent	Henley Intl.
K921436	SONICATOR PLUS	Apr 27, 1993	Substantially Equivalent	Mettler Electronics Corp.
K921952	ULTRA III	Mar 09, 1993	Substantially Equivalent	Excel Tech. , Ltd.
K920939	DYNATRON 300 ULRASOUND	Mar 04, 1993	Substantially Equivalent	Dynatronics Laser Corp.
K923797	MODEL 25 THERAPEUTIC ULTRASOUND -- MODIFIED	Nov 06, 1992	Substantially Equivalent	Rich-Mar Corp.
K911733	INTELECT, MODEL 245	Dec 17, 1991	Substantially Equivalent	Chattanooga Group, Inc.
K902875	INTELECT 750 MP	Sep 27, 1990	Substantially Equivalent	Chattanooga Group, Inc.
K902860	INTELECT 170	Sep 27, 1990	Substantially Equivalent	Chattanooga Group, Inc.
K900189	CURAPULS 403 DIATHERMY UNIT	Sep 18, 1990	Substantially Equivalent	Henley Intl.
K895690	ULTRA (THERAPEUTIC ULTRASOUND DEVICE)	Feb 20, 1990	Substantially Equivalent	Excel Tech. , Ltd.
K883893	OMNISOUND(TM) 3000	Nov 01, 1988	Substantially Equivalent	Physio Technology, Inc.
K872909	SIEMENS SONODYNATOR 834, ULTRASOUND/STIMULATION	Jan 13, 1988	Substantially Equivalent	Elmed, Inc.
K872394	SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT	Sep 03, 1987	Substantially Equivalent	Henley Intl.
K871647	STIMULATOR, ULTRASOUND AND MUSCLE	Jun 29, 1987	Substantially Equivalent for Some Indications	Amy West
K861837	FISCHER/KRYSTAL THERAPEUTIC ULTRASOUND	Aug 07, 1986	Substantially Equivalent	Fischer Industries, Inc.
K844217	RICH-MAR DELTA 330 HV	Nov 27, 1984	Substantially Equivalent	Rich-Mar Corp.
K843351	OMNISTIM II COMBIN. THERAPY SYS	Sep 18, 1984	Substantially Equivalent	Physio Technology, Inc.
K813594	INTELECT MODEL 700	Feb 22, 1982	Substantially Equivalent	Chattanooga Group, Inc.
K810526	RICH-MAR HV II SELECT-A-PULSE	Apr 03, 1981	Substantially Equivalent	Rich-Mar Corp.
K772287	MUSCLE STIMULATOR	Jan 13, 1978	Substantially Equivalent	Rich-Mar Corp.
K771157	RM VI-HV	Jul 21, 1977	Substantially Equivalent	Rich-Mar Corp.