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Device Explorer · FDA GUDID · GMDN 11989

External electric-heating core temperature regulation system pad

An electrically-heated underlay or overlay intended to provide heat under or over a patient as part of an external electric-heating core temperature regulation system intended to elevate a patient’s core body temperature, typically in surgical and intensive ca

US‑registered devices117in commercial distribution
Companies12labelers on GUDID
Single‑use3%of device records
Sterile9%labelled sterile
Prescription2%Rx‑only share
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Share of device records

Joicom Corporation3126%
Conair Corporation2521%
Matsum Inc1815%
Ningbo Kangheng Appliance Co., Ltd.1412%
Kaz Usa, Inc.119%
Boxout, Llc87%
Djo, Llc33%
Hsin Ten Health & Wealth Industry(Hefei)Co., Ltd.22%

Top labelers

CompanyDevicesShare
Joicom Corporation3126%
Conair Corporation2521%
Matsum Inc1815%
Ningbo Kangheng Appliance Co., Ltd.1412%
Kaz Usa, Inc.119%
Boxout, Llc87%
Djo, Llc33%
Hsin Ten Health & Wealth Industry(Hefei)Co., Ltd.22%
Vive Health Llc22%
Shanghai Careus Medical Product Co., Ltd.11%
Vita Heat Medical11%
Pintler Medical, Llc11%

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

Brand names on the register (sample)

Heating PadHeating padSOQIVenture HeatPatient Warming MattressViveBodyMedRenphoiDOO Heating PadRENPHO Heating PadIDOO Heating Pad for CrampsMind+Body CareMeijerSoftHeatSoftheatCHATTANOOGA

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

FDA product codes

CodeNameDevices
IRTPad, Heating, Powered110
IRTPAD, HEATING, POWERED7
ISAMassager, Therapeutic, Electric4
IRQUnit, Heating, Powered2
DWJSystem, Thermal Regulating2

GMDN & GCC registration

  • GMDN code 11989 · non‑implantable
  • Single‑use 3% · sterile 9% · Rx‑only 2% · OTC 52%
  • 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 external electric-heating core temperature regulation system pad products are registered in the US?

117 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "External electric-heating core temperature regulation system pad", from 12 companies. The largest labeler is Joicom Corporation with 26% of records.

Which FDA product codes apply?

IRT (Pad, Heating, Powered), IRT (PAD, HEATING, POWERED), ISA (Massager, Therapeutic, Electric), IRQ (Unit, Heating, Powered)

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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