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Device Explorer · FDA GUDID · GMDN 61429

Inflatable hot/cold therapy pack/electric pump

A non-sterile assembly of devices intended for localized thermal and compression therapy to facilitate the treatment of a variety of adverse conditions resulting from musculoskeletal injury (e.g., pain, swelling, inflammation). It includes one or more hot and/

US‑registered devices162in commercial distribution
Companies6labelers on GUDID
Single‑use27%of device records
Sterile0%labelled sterile
Prescription80%Rx‑only share
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Share of device records

Zenith Technical Innovations, Llc5031%
Portable Therapeutix4226%
Breg, Inc.3421%
Bio Compression Systems, Inc2415%
Wmi Enterprises, Llc96%
Fuzhou Blue Crystal Industrial Co.,Ltd.32%

Top labelers

CompanyDevicesShare
Zenith Technical Innovations, Llc5031%
Portable Therapeutix4226%
Breg, Inc.3421%
Bio Compression Systems, Inc2415%
Wmi Enterprises, Llc96%
Fuzhou Blue Crystal Industrial Co.,Ltd.32%

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

Brand names on the register (sample)

Recovery+ Go Compression UnitRecovery+ Go Hip Thermal Compression WrapRecovery+ Go Ankle Thermal Compression WrapRecovery+ Go Wrist Thermal Compression WrapRecovery+ Go Cervical Thermal Compression WrapRecovery+ Go Left Shoulder Thermal Compression WRecovery+ Go Right Shoulder Thermal Compression Recovery+ Go Knee Thermal Compression WrapRecovery+ Go Lumbar Thermal Compression WrapTherm-XBio Compression Systems Cryo Insert Hand WristBio Compression Systems Cryo Insert ElbowBio Compression Systems Cryo Insert BackBio Compression Systems Multi-Flo DVT Model IC-1Bio Compression Systems Multi-Flo DVT Model IC-1Bio Compression Systems Multi-Flo DVT Model IC-1

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

FDA product codes

CodeNameDevices
IRPMassager, Powered Inflatable Tube115
ILOPack, Hot Or Cold, Water Circulating73
JOWSleeve, Limb, Compressible61
IMEPack, Hot Or Cold, Reusable39
IMEPack, Hot Or Cold, Reuseable11
JOWSLEEVE, LIMB, COMPRESSIBLE9

GMDN & GCC registration

  • GMDN code 61429 · non‑implantable
  • Single‑use 27% · sterile 0% · Rx‑only 80% · OTC 19%
  • 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 inflatable hot/cold therapy pack/electric pump products are registered in the US?

162 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Inflatable hot/cold therapy pack/electric pump", from 6 companies. The largest labeler is Zenith Technical Innovations, Llc with 31% of records.

Which FDA product codes apply?

IRP (Massager, Powered Inflatable Tube), 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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