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Device Explorer · FDA GUDID · GMDN 37240

Musculoskeletal hot/cold therapy pack, reusable

A non-powered device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sport

US‑registered devices574in commercial distribution
Companies60labelers on GUDID
Single‑use9%of device records
Sterile2%labelled sterile
Prescription7%Rx‑only share
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Share of device records

Vive Health Llc8615%
Shanghai Bingfan Industrial Co., Ltd.6912%
Djo, Llc397%
Deroyal Industries, Inc.397%
Anhui Zhanzun Industrial Co.,Ltd.346%
Chengdu Cryo-Push Medical Technology Co.,Ltd.234%
Jiangsu Huanyi Industrial Co. Ltd224%
Brownmed, Inc.214%

Top labelers

CompanyDevicesShare
Vive Health Llc8615%
Shanghai Bingfan Industrial Co., Ltd.6912%
Djo, Llc397%
Deroyal Industries, Inc.397%
Anhui Zhanzun Industrial Co.,Ltd.346%
Chengdu Cryo-Push Medical Technology Co.,Ltd.234%
Jiangsu Huanyi Industrial Co. Ltd224%
Brownmed, Inc.214%
Manamed, Inc.193%
Anhui Kamt Ice Pack Co.,Ltd.183%
Merchsource, Llc173%
Ideavillage Products Corp132%

Company = labeler of record on GUDID. 60 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ZhanzunzhanzunTHERMA ZONEHot PackmagicgelMagic gelFreeze SleeveBingfanCRYOPUSHGuanyinsunwin momInstant+ reusable gel packREXALL KIDS GEL BEAD COMPRESS 1CTVEGAUp&UpDONJOY PERFORMANCE

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

FDA product codes

CodeNameDevices
IMEPack, Hot Or Cold, Reusable411
IMEPack, hot or cold, reusable74
ITQJOINT, KNEE, EXTERNAL BRACE27
KYRBag, Ice21
IMEPack, Hot Or Cold, Reuseable11
IRPMassager, Powered Inflatable Tube11

GMDN & GCC registration

  • GMDN code 37240 · non‑implantable
  • Single‑use 9% · sterile 2% · Rx‑only 7% · OTC 37%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 9Width (Inch) · 9Area/Surface Area (Square inch) · 5

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

How many musculoskeletal hot/cold therapy pack, reusable products are registered in the US?

574 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Musculoskeletal hot/cold therapy pack, reusable", from 60 companies. The largest labeler is Vive Health Llc with 15% of records.

Which FDA product codes apply?

IME (Pack, Hot Or Cold, Reusable), IME (Pack, hot or cold, reusable), ITQ (JOINT, KNEE, EXTERNAL BRACE), KYR (Bag, Ice)

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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