FDA.reportPublic FDA data

Physical therapy ultrasound system

Definition
An assembly of devices designed to produce and deliver ultrasonic waves that penetrate tissues and produce both thermal and nonthermal (e.g., mechanical and cavitation) effects to treat pain (e.g., muscle, tendon, joint) and as an aid in the healing of soft-tissue injuries (e.g., ulcerations, bursitis). It typically consists of a radio-frequency (RF) generator (frequencies from one to three megahertz are typical), a cable that transmits the RF energy to the applicator, and an applicator including a piezoelectric transducer that applies the ultrasonic energy to the patient's tissues through the skin.
GUDID devices
125
Last updated
2026-07-17 21:59:27

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00857599005325sam 3.0 multi-hour continuous ultrasound device for home useZETROZ SYSTEMS, LLCOA3252026-06-23
03661690000052Focal OneEDAP-TMS FRANCETMS 2393202018-06-11
00092237611548Roscoe MedicalDrive Devilbiss HealthcareDU30352016-10-13
00092237611562LG Med SupplyDrive Devilbiss HealthcareDU30372016-10-13
00092237611630UltraTENSIIDrive Devilbiss HealthcareDU60122016-10-13
00092237616437Roscoe MedicalDrive Devilbiss HealthcareDQ8000W12016-10-12
00092237616444Roscoe MedicalDrive Devilbiss HealthcareDQ8000W52016-10-12
00092237616741Roscoe MedicalDrive Devilbiss HealthcareDQ92752016-10-12
00092237616802Roscoe MedicalDrive Devilbiss HealthcareDU10252016-10-13
00092237618721Direct SupplyDrive Devilbiss HealthcareDS-ULTRSND2016-10-12
00092237618868Mountain ValleyDrive Devilbiss HealthcareDU30382016-10-13
00857599005271sam 2.0 OA multi-hour continuous ultrasound device for home useZETROZ SYSTEMS, LLCSAM 2.0 OA242026-04-07
00858703006009Omnisound 3000EACCELERATED CARE PLUS CORP1203000E2016-08-16
03661690000205Dynamic Focal ProbeEDAP-TMS FRANCETMS 9020812018-06-13
06973512860421HuameiShandong Huamei Technology Co.,Ltd.HM-PL2002020-11-04
06973512860438HuameiShandong Huamei Technology Co.,Ltd.HM-PL3002020-11-04
06973512860445HuameiShandong Huamei Technology Co.,Ltd.HM-PL6002020-11-04
07290103421229Reusable PatchNANOVIBRONIX INC.PRP-202019-07-28
07290103421250Reusable Facial PatchNANOVIBRONIX INC.PRP-402019-07-28
10660584000147Dynatron 25 Series 125BDynatronics CorporationD125B2016-09-24
00850033615227Echo Ultrasound Device (PRC) THERMOTEK, INC.0V52XX1001JK01-CTN2026-02-23
00850033615258Echo Ultrasound Device (PRC)THERMOTEK, INC.0V52XX1001JK012026-02-23
00850033615289Echo Ultrasound Device (USA)THERMOTEK, INC.0V52XX1002JK01-CTN2026-02-23
00850033615340Echo Ultrasound Device (USA)THERMOTEK, INC.0V52XX1002JK012026-02-23
00850033615371Echo BOX, DRESSING & GEL POD PACK, USND, PRCTHERMOTEK, INC.0V52XX1003JK01 2026-02-23
00850033615388Echo CTN, DRESSINGS, USND, PRC, QTY 4 BOXESTHERMOTEK, INC.0V52XX1003JK01-CTN2026-02-23
00850033615425Echo Ultra Sound Gel Pods, CartonTHERMOTEK, INC.0V52XX1004JK01-CTN2026-02-23
00850033615487Echo Ultra Sound Gel Pod, SingleTHERMOTEK, INC.0V52XX1004JK012026-02-23
00850033615500Echo APPLICATOR, SINGLE, USNDTHERMOTEK, INC.0V52XX1005JK012026-02-23
00850033615517Echo POWER SUPPLY, CORD, SINGLE, USNDTHERMOTEK, INC.0V52XX1006JK012026-02-23
00850033615531Echo BELT CLIP, DEVICE PRTCTR, SNGL,USNDTHERMOTEK, INC.0V52XX1007JK012026-02-23
00850033615555Echo ARM STRAP, DEVICE PRTCTR, SNG, USNDTHERMOTEK, INC.0V52XX1008JK012026-02-23
00850033615562Echo GEL, TUBE, SINGLE, USNDTHERMOTEK, INC.0V52XX1009JK012026-02-23
00850033615586echoRx, MANUAL, USER, SINGLE, USNDTHERMOTEK, INC.0V52XX1010JK012026-02-23
00850033615593echoRx, GUIDE,QUICK START,SNGL,USNDTHERMOTEK, INC.0V52XX1011JK012026-02-23
00850033615623Echo CTN, DRESSINGS, USND, USA, QTY 4 BOXESTHERMOTEK, INC.0V52XX1012JK01-CTN 2026-02-23
00850033615630Echo BOX, DRESSING & GEL POD PACK, USND, USATHERMOTEK, INC.0V52XX1012JK012026-02-23
03661690000267Focal OneEDAP-TMS FRANCETMS 2347802026-01-26
03661690000342Endorectal ProbeEDAP-TMS FRANCETMS 2537282026-01-26
08720618311108Sonopuls 190Enraf-Nonius B.V.16319512025-02-11
08720618311221Sonopuls 190Enraf-Nonius B.V.16319402025-02-11
03661690000014AblapakEDAP-TMS FRANCETMS 2277102018-06-08
03661690000076Ablatherm Endorectal ProbeEDAP-TMS FRANCEEDP 9009002018-06-08
03661690000144Ablatherm Integrated ImagingEDAP-TMS FRANCEEDP9008002016-09-21
03661690000199ABLATHERM FUSIONEDAP-TMS FRANCEEDP 9008002018-02-23
03661690000069FocalpakEDAP-TMS FRANCETMS 2393052018-06-11
07290103421014PainShieldNANOVIBRONIX INC.PS-302019-07-28
00857599005202sam X1ZETROZ SYSTEMS, LLCSA5512022-09-29
07290103421267PainShield MD Plus Supplies KitNANOVIBRONIX INC.3.02022-05-16
07290103421311PainShield MD PlusNANOVIBRONIX INC.3.02022-05-16
B854M20Khan Kinetic Treatment Device (KKT-M2)Optima Health Solutions International CorporationKKT-M22022-03-24
00857599005196sam 2.0 Long Duration Ultrasound Device for Home UseZETROZ SYSTEMS, LLCSA2712021-11-30
03661690000243FocalPakEDAP-TMS FRANCEEDP 9014002021-03-04
07290103421168PainShield MD Supplies KitNANOVIBRONIX INC.3.0 2020-12-22
07290103421236PainShield MD KitNANOVIBRONIX INC.3.02020-12-22
06973512860414HuameiShandong Huamei Technology Co.,Ltd.HM-PL1002020-10-29
00888912021883CHATTANOOGADJO, LLC27382016-09-12
00888912022019CHATTANOOGADJO, LLC27822016-09-15
00888912022057CHATTANOOGADJO, LLC27912016-09-15
00888912022095CHATTANOOGADJO, LLC27952016-09-15
00888912043359CHATTANOOGADJO, LLCINT0012016-09-15
00888912292153CHATTANOOGADJO, LLC2738-102016-09-15
00888912292160CHATTANOOGADJO, LLC2738-22016-09-15
00888912292740CHATTANOOGADJO, LLC27602016-09-15
00888912293013CHATTANOOGADJO, LLC27632016-09-15
00888912293907CHATTANOOGADJO, LLC2782-102016-09-15
00888912293914CHATTANOOGADJO, LLC2782-22016-09-15
00888912293945CHATTANOOGADJO, LLC27832016-09-15
00888912294171CHATTANOOGADJO, LLC27872016-09-15
00888912294188CHATTANOOGADJO, LLC27882016-09-15
00888912294195CHATTANOOGADJO, LLC2788-102016-09-15
00888912294201CHATTANOOGADJO, LLC2788-22016-09-15
00888912294447CHATTANOOGADJO, LLC27922016-09-15
00888912294553CHATTANOOGADJO, LLC2795-102016-09-15
00888912294560CHATTANOOGADJO, LLC2795-22016-09-15
00888912294607CHATTANOOGADJO, LLC27962016-09-15
00888912294614CHATTANOOGADJO, LLC2796-102016-09-15
00888912294621CHATTANOOGADJO, LLC2796-22016-09-15
00888912294720CHATTANOOGADJO, LLC27972016-09-15
00888912294768CHATTANOOGADJO, LLC27982016-09-15