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

Product Code: IMG

Physical Medicine Therapeutic Ultrasonic Devices (Certified)

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: Ultrasonic Therapy Products. [1050.10]

Code of Federal Regulations: 890.5860


Radiation TypeAcoustic
Radition SafetyProduct
Annual ReportsYes

Products Classified as IMG

5091Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep HeatUltrasound And Muscle Stimulator.

Total Product Life Cycle (TPLC) Devices

5091Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep HeatUltrasound And Muscle Stimulator.

FDA Consensus Standards

Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat [32412]21 CFR §890.5860 🔎

Pre-market Notifications for IMG

K153559OmniVersa Multi-Modality Therapy System And Omnistim FX2 Professional Therapy SystemAccelerated Care Plus (ACP)
K150436ComboRehabSHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
K150353BTL-4000BTL INDUSTRIES, INC
K121059SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIMZIMMER MEDIZINSYSTEMS GMBH
K120217SONICSTIMU COMBO THERAPEUTIC DEVICESHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
K111482SONICATOR PLUS 920METTLER ELECTRONICS CORP.
K102524FUTURADR. OLIVER WENKER, M.D., M.B.A.
K102190WINSTIMJOHARI DIGITAL HEALTHCARE, LTD.
K092627CT2011 SONICSTIMU PAIN RELIEF DEVICESHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
K071137SONICATOR PLUS 940, MODEL ME940METTLER ELECTRONICS CORP.
K063728TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEMALFA TECH MEDICAL SYSTEMS, LTD.
K063135SONIC-STIMNAIMCO, INC.
K052340DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEMALFA TECH MEDICAL SYSTEMS, LTD.
K040285VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORTABLE COMBO AND STIM (GENERAL LINE DEALERCHATTANOOGA GROUP
K040121DERMAWAVE 5000 COMBI MAX SYSTEMDERMAWAVE, LLC

Global Unique Device Identification Database

00816864020760STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
00816864020753STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
00816864020746STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
00816864020739STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
00816864020722STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
00816864020715STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
00816864020708STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
00816864020654STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
00816864020647STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
00816864020623STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
00816864020616STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
00816864020609STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
00816864020432STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
00816864020234STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
00816864020203STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Maude Adverse Events

CHATTANOOGA LEGEND XT 4CH COMBO PKG, US STD, 5CM APPLDJO, LLC2020-03-23
CHATTANOOGA INTELECT LEGEND XT COMBOUS STDDJO, LLC2020-02-24
RICHMARCOMPASS HEALTH BRANDS2019-11-26
RICHMARCOMPASS HEALTH BRANDS2019-10-23
RICHMARCOMPASS HEALTH BRANDS2019-10-03
CHATTANOOGA INTELECT LEGEND XT COMBOUS STDDJO, LLC2019-09-25
CHATTANOOGA INTELECT TRANSPORT 2CH STIM US STDDJO, LLC2019-09-06
CHATTANOOGA INTELECT TRANSPORT COMBO PKG US STDDJO, LLC2019-09-04
CHATTANOOGA VECTRA GENISYS 4CH STIM PKG, US STD W/CARTDJO, LLC2019-08-21
CHATTANOOGA INTELECT TRANSPORT COMBO PKG US STDDJO, LLC2019-07-10
CHATTANOOGA INTELECT TRANSPORT 2CH STIM US STDDJO, LLC2019-06-26
CHATTANOOGA INTELECT TRANSPORT COMBO PKG US STDDJO, LLC2019-06-26
CHATTANOOGA INTELECT TRANSPORT 2CH STIM US STDDJO, LLC2019-06-25
CHATTANOOGADJO, LLC2019-05-01
INTELECT MOBILE INT'L STD.DJO, LLC2019-01-21
CHATTANOOGADJO, LLC2017-12-12
SONICATOR PLUS 940ITO CO., LTD. TSUKUBA FACTORY2017-04-05
CHATTANOOGADJO, LLC2016-12-13
CHATTANOOGADJO, LLC2016-08-26
CHATTANOOGADJO, LLC2016-08-23
CHATTANOOGODJO, LLC2016-08-15
CHATTANOOGADJO, LLC2016-07-25
INTELECT LEGEND XTCHATTANOOGA GROUP2016-07-19
CHATTANOOGADJO, LLC2016-03-02
CHATTANOOGADJO, LLC2015-08-21
CHATTANOOGADJO, LLC2015-06-19
CHATTANOOGADJO LLC2015-02-23
CHATTANOOGADJO GLOBAL2015-02-20
CHATTANOOGA CPS400CHATTANOOGA GROUP INC2014-07-25
FUTURA PROULTRATONE SCIENTIFIC INSTRUMENTS, LTD2014-06-03
INTELECT COMBOCHATTANOOGA GROUP2014-02-25
CHATTANOOGA INTELECT LEGENDDJO, LLC2013-07-24
SONICATOR PLUS 940METTLER ELECTRONICS CORP.2013-05-20
VECTRA GENISYS 2CH COMBO PKGDJO, LLC2013-04-12
DYNATRON D650DYNATRONICS2013-02-05
INTELECT LEGENDRICH-MAR, INC.2012-09-06
RICHMARRICH-MAR, INC.2012-09-06
LEGEND 2CDJO, LLC2012-06-14
CHATANOOGA2012-05-16
INTELECT XT 2CH COMBO PKGDJO, LLC2012-05-14
VECTRA GENISYSDJO, LLC2012-04-03
VECTRA GENISYSCHATTANOOGA GROUP INC2012-03-09
VECTRA GENISYS 2CH COMBO PKGDJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.2011-10-18
INTELECTDJO GLOBAL2011-10-05
INTELLECT MOBILE COMBODJ ORTHOPEDICS DE MEXICO2011-09-22
INTELLECT MOBILE COMBODJ ORTHOPEDICS DE MEXICO2011-09-22
INTELECT XT 2CH COMBO PKGDJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.2011-09-06
CHATTANOOGADJO GLOBAL2011-09-01
SOLUTIONS 4CH COMBO PKGDJO GLOBAL2011-08-25
INTELECT TERANSPORT 2C STIMDJO GLOBAL2011-07-28
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