Consulting Wallah › Device Explorer › Equipment & monitoring › Physical therapy ultrasound system
Device Explorer · FDA GUDID · GMDN 11248

Physical therapy ultrasound system

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-ti

US‑registered devices99in commercial distribution
Companies16labelers on GUDID
Single‑use10%of device records
Sterile0%labelled sterile
Prescription84%Rx‑only share
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Share of device records

Djo, Llc3232%
Thermotek, Inc.1717%
Drive Devilbiss Healthcare1515%
Nanovibronix Inc.77%
Zetroz Systems, Llc55%
Shandong Huamei Technology Co.,Ltd.44%
Edap-Tms France44%
Mettler Electronics Corp.44%

Top labelers

CompanyDevicesShare
Djo, Llc3232%
Thermotek, Inc.1717%
Drive Devilbiss Healthcare1515%
Nanovibronix Inc.77%
Zetroz Systems, Llc55%
Shandong Huamei Technology Co.,Ltd.44%
Edap-Tms France44%
Mettler Electronics Corp.44%
Axiosonic, Llc33%
Enraf-Nonius B.V.22%
Zimmer Medizinsysteme Gmbh11%
Hill Laboratories Co.11%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PainShield MD PlusPainShield MD Plus Supplies KitReusable Facial PatchPainShield MD KitReusable PatchPainShield MD Supplies KitPainShieldHuameiSoleo SonoEndorectal ProbeFocal OneFocalPakDynamic Focal ProbeCHATTANOOGAAxioSonic PhysiotherapyJAS Pulse 3MHz

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep He41
PFWStationary Ultrasonic Diathermy Device For Use In Applying T30
IMGSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERA26
IMGStimulator, Ultrasound And Muscle, For Use In Applying Thera15
PLPHigh Intensity Ultrasound System For Prostate Tissue Ablatio10
IMIUltrasonic diathermy for use in applying therapeutic deep he6

GMDN & GCC registration

  • GMDN code 11248 · non‑implantable
  • Single‑use 10% · sterile 0% · Rx‑only 84% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Pound) · 3Weight (Gram) · 2Height (Inch) · 1Width (Inch) · 1Length (Inch) · 1

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many physical therapy ultrasound system products are registered in the US?

99 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Physical therapy ultrasound system", from 16 companies. The largest labeler is Djo, Llc with 32% of records.

Which FDA product codes apply?

IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep He), PFW (Stationary Ultrasonic Diathermy Device For Use In Applying T), IMG (STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERA), IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Thera)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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