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Device Explorer · FDA GUDID · GMDN 40485

Circulating-fluid localized thermal therapy system pack, single-use

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 devices232in commercial distribution
Companies13labelers on GUDID
Single‑use85%of device records
Sterile13%labelled sterile
Prescription72%Rx‑only share
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Share of device records

Deroyal Industries, Inc.5925%
Breg, Inc.5925%
Thermotek, Inc.3917%
Ossur Americas, Inc.209%
Gentherm Medical, Llc188%
Adroit Medical Systems, Inc.188%
Innovative Medical Equipment, Llc63%
Advanced Ambulatory, Inc.31%

Top labelers

CompanyDevicesShare
Deroyal Industries, Inc.5925%
Breg, Inc.5925%
Thermotek, Inc.3917%
Ossur Americas, Inc.209%
Gentherm Medical, Llc188%
Adroit Medical Systems, Inc.188%
Innovative Medical Equipment, Llc63%
Advanced Ambulatory, Inc.31%
Top Shelf Manufacturing, Llc31%
Suzhou Minhua Medical Apparatus Supplies Co., Ltd.21%
Hilotherm Gmbh21%
Prestige Ameritech, Ltd.21%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

/Cold RushCold Rush CompactLower face cuff without linkLower face cuff with linkAqueCoolThermaZoneTHERAPY SYSTEM, ARTEK PRO-02ThermoTek WRAP, KN/FL, SG GRD,CF,EXT SPU, UFThermoTek WRAP,WRIST/HAND,SPU,UF,QTY 10 CTNThermoTek WRAP,SHD 1/2 ARM,W/HRN,SPU,UF,QTY 10 CThermoTek WRAP, KNE,STD,HL,SPU,UF, QTY 10 CTNThermoTek WRAP,DLX SHLDR,1/2 ARM,SPU,UF,QTY 10 CThermoTek WRAP, KNEE, MED, SPU, UF,QTY 10 CTNThermoTek WRAP, HIP, STND, SPU, UF, QTY 10 CTNThermoTek WRAP,KNEE-HL,DLX,SG,GD,SPU,UF QTY 10 C

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 Circulating171
ILOPack, hot or cold, water circulating79
JOWSleeve, Limb, Compressible37
IMEPack, Hot Or Cold, Reusable7
ITQJoint, Knee, External Brace5
IQIOrthosis, Limb Brace1

GMDN & GCC registration

  • GMDN code 40485 · non‑implantable
  • Single‑use 85% · sterile 13% · Rx‑only 72% · 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

Width (Inch) · 18Length (Inch) · 18Weight (Pound) · 18

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

How many circulating-fluid localized thermal therapy system pack, single-use products are registered in the US?

232 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, single-use", from 13 companies. The largest labeler is Deroyal Industries, Inc. with 25% of records.

Which FDA product codes apply?

ILO (Pack, Hot Or Cold, Water Circulating), ILO (Pack, hot or cold, water circulating), JOW (Sleeve, Limb, Compressible), 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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