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Device Explorer · FDA GUDID · GMDN 60707

Circulating-fluid localized thermal/compression therapy system control unit

An electrically-powered device intended to pump heated and/or cooled water through an externally applied wrap (not included), and to air inflate the wrap, for localized thermal and compression therapy to facilitate the treatment of a variety of adverse conditi

US‑registered devices110in commercial distribution
Companies6labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription95%Rx‑only share
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Share of device records

Avanos Medical, Inc.8981%
Daesung Maref Co.,Ltd.1413%
Zamar Medical D.O.O.33%
Vive Health Llc22%
Chengdu Cryo-Push Medical Technology Co.,Ltd.11%
Aquilo Sports L.L.C.11%

Top labelers

CompanyDevicesShare
Avanos Medical, Inc.8981%
Daesung Maref Co.,Ltd.1413%
Zamar Medical D.O.O.33%
Vive Health Llc22%
Chengdu Cryo-Push Medical Technology Co.,Ltd.11%
Aquilo Sports L.L.C.11%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Dr. AktiveZT CLINICZT Cube - ZC3Z-ONEAquilo SportsViveGame Ready* SystemGAME READY* MED4 Elite* SystemGAME READY* Med4 Elite* Accessory KitMed4Elite AccessoriesGAME READY* MED4 Elite* Control UnitGame Ready GRPRO 2.1 Control Unit EducationGame Ready GRPRO 2.1 Control Unit - DemoGame Ready GRPRO 2.1 Control Unit RentalGame Ready Med4 Elite Control UnitGame Ready

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

FDA product codes

CodeNameDevices
ILOPack, Hot Or Cold, Water Circulating82
IRPMassager, Powered Inflatable Tube68
IRPMassager, powered inflatable tube28
ILOPack, hot or cold, water circulating28
ITQJoint, Knee, External Brace1

GMDN & GCC registration

  • GMDN code 60707 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 95% · OTC 4%
  • 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.

How many circulating-fluid localized thermal/compression therapy system control unit products are registered in the US?

110 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Circulating-fluid localized thermal/compression therapy system control unit", from 6 companies. The largest labeler is Avanos Medical, Inc. with 81% of records.

Which FDA product codes apply?

ILO (Pack, Hot Or Cold, Water Circulating), IRP (Massager, Powered Inflatable Tube), IRP (Massager, powered inflatable tube), ILO (Pack, hot or cold, water circulating)

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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