An electrically-powered device intended to be used as part of a localized circulating-fluid thermal therapy system to pump heated and/or cooled fluid (e.g., water) through an externally applied pack (not included) for localized hot and/or cold therapy for the
| Company | Devices | Share |
|---|---|---|
| Deroyal Industries, Inc. | 126 | 42% |
| Breg, Inc. | 46 | 15% |
| Djo, Llc | 45 | 15% |
| Polar Products, Inc. | 18 | 6% |
| Prestige Ameritech, Ltd. | 16 | 5% |
| Ossur Americas, Inc. | 12 | 4% |
| Adroit Medical Systems, Inc. | 8 | 3% |
| Ultra Pain Products Inc | 6 | 2% |
| Gentherm Medical, Llc | 4 | 1% |
| Innovative Medical Equipment, Llc | 3 | 1% |
| Top Shelf Manufacturing, Llc | 3 | 1% |
| Stryker Corporation | 2 | 1% |
Company = labeler of record on GUDID. 20 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| ILO | Pack, hot or cold, water circulating | 189 |
| ILO | Pack, Hot Or Cold, Water Circulating | 119 |
| JOW | SLEEVE, LIMB, COMPRESSIBLE | 1 |
Use these as the dimensions to specify in a tender line.
298 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 control unit", from 20 companies. The largest labeler is Deroyal Industries, Inc. with 42% of records.
ILO (Pack, hot or cold, water circulating), ILO (Pack, Hot Or Cold, Water Circulating), JOW (SLEEVE, LIMB, COMPRESSIBLE)
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.