Consulting Wallah › Device Explorer › Other devices › Medium-wave diathermy treatment system
Device Explorer · FDA GUDID · GMDN 47575

Medium-wave diathermy treatment system

An assembly of devices designed to produce a therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio-frequency (RF) bands of 0.5 megahertz (MHz) to 1 MHz. It typically consis

US‑registered devices66in commercial distribution
Companies8labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription36%Rx‑only share
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Share of device records

Unibell Srl4162%
Indiba Sa.1117%
Capenergy Medical Sl58%
Mectronic Medicale Srl35%
Zimmer Medizinsysteme Gmbh23%
Domino Srl23%
Xod Inc.12%
Termosalud Sl12%

Top labelers

CompanyDevicesShare
Unibell Srl4162%
Indiba Sa.1117%
Capenergy Medical Sl58%
Mectronic Medicale Srl35%
Zimmer Medizinsysteme Gmbh23%
Domino Srl23%
Xod Inc.12%
Termosalud Sl12%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Tecarpuls IIThermoTKWonder TouchCapenergyTERMOSALUDCOMPACT PROCOMPACT PLUSCOMPACT LITEINDIBA ACTIV - ACTIV CT9INDIBA DEEP CARE - EVONYINDIBA ACTIV - AT7INDIBA ACTIV - CT7INDIBA ACTIV - CT8INDIBA ACTIV - ACTIV 701INDIBA ACTIV - ACTIV 801INDIBA ACTIV - ACTIV 902

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

FDA product codes

CodeNameDevices
PBXMassager, Vacuum, Radio Frequency Induced Heat62
PBXMassager, vacuum, radio frequency induced heat9

GMDN & GCC registration

  • GMDN code 47575 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 36% · OTC 9%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

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

No closely related category with 50+ devices.

How many medium-wave diathermy treatment system products are registered in the US?

66 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Medium-wave diathermy treatment system", from 8 companies. The largest labeler is Unibell Srl with 62% of records.

Which FDA product codes apply?

PBX (Massager, Vacuum, Radio Frequency Induced Heat), PBX (Massager, vacuum, radio frequency induced heat)

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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