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Device Explorer · FDA GUDID · GMDN 32965

Circulating-fluid localized thermal therapy system pack, reusable

A device intended to be applied to part of the body as part of a circulating-fluid localized thermal therapy system to provide localized heat and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and

US‑registered devices187in commercial distribution
Companies12labelers on GUDID
Single‑use10%of device records
Sterile3%labelled sterile
Prescription44%Rx‑only share
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Share of device records

Djo, Llc8143%
Daesung Maref Co.,Ltd.3217%
Innovative Medical Equipment, Llc147%
Chengdu Cryo-Push Medical Technology Co.,Ltd.126%
C2Dx, Inc.126%
Manamed, Inc.116%
Medline Industries, Inc.95%
Stryker Corporation84%

Top labelers

CompanyDevicesShare
Djo, Llc8143%
Daesung Maref Co.,Ltd.3217%
Innovative Medical Equipment, Llc147%
Chengdu Cryo-Push Medical Technology Co.,Ltd.126%
C2Dx, Inc.126%
Manamed, Inc.116%
Medline Industries, Inc.95%
Stryker Corporation84%
Vive Health Llc42%
Zamar Medical D.O.O.21%
Nice Recovery Systems Llc11%
Walgreen Co.11%

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

Brand names on the register (sample)

T/PADT/PadMul-T-PadCryoRxCRYOPUSHFace Thermic WrapJaw Thermic WrapAIRCASTDONJOY PERFORMANCEDONJOYNICEThermaZoneTPIVTPT9TPS2T/Pump

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 Circulating110
ILOPack, hot or cold, water circulating103
IPYOrthosis, Lumbo-Sacral3
IMEPack, Hot Or Cold, Reusable2
IMEPack, hot or cold, reusable2
IRPMassager, Powered Inflatable Tube1

GMDN & GCC registration

  • GMDN code 32965 · non‑implantable
  • Single‑use 10% · sterile 3% · Rx‑only 44% · OTC 14%
  • 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 therapy system pack, reusable products are registered in the US?

187 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Circulating-fluid localized thermal therapy system pack, reusable", from 12 companies. The largest labeler is Djo, Llc with 43% of records.

Which FDA product codes apply?

ILO (Pack, Hot Or Cold, Water Circulating), ILO (Pack, hot or cold, water circulating), IPY (Orthosis, Lumbo-Sacral), IME (Pack, Hot Or Cold, Reusable)

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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