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Device Explorer · FDA GUDID · GMDN 35147

Musculoskeletal infrared phototherapy unit, non-wearable

An electrically-powered device intended for use in the home or clinical setting to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in

US‑registered devices237in commercial distribution
Companies35labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription24%Rx‑only share
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Share of device records

Healthlight Llc6226%
Multi Radiance Medical3816%
Thermotex Therapy Systems Ltd.125%
Asa Srl125%
Wuhan Phomed Technology Co., Ltd.115%
Health Body World Supply Inc.115%
Anodyne Therapy, L.L.C.94%
Djo, Llc83%

Top labelers

CompanyDevicesShare
Healthlight Llc6226%
Multi Radiance Medical3816%
Thermotex Therapy Systems Ltd.125%
Asa Srl125%
Wuhan Phomed Technology Co., Ltd.115%
Health Body World Supply Inc.115%
Anodyne Therapy, L.L.C.94%
Djo, Llc83%
Led Intellectual Properties Llc63%
Migun Life Co., Ltd63%
A & A Medical Supplies Inc.63%
Migun Life Inc63%

Company = labeler of record on GUDID. 35 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TheraLight 360 Full Body WellnessVelasII Therapy Laser SystemCureLight Medical Diode Laser SystemsCureBioLumadocZOOM WELLNESSBashanHUA TUO BRAND TDP Heat LampHWATO TDP Heat LampRelaxCHATTANOOGALUMIWAVEFUSION PBM Plus LightANODYNE THERAPY,LLCAnodyne TherapyCARELight

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

FDA product codes

CodeNameDevices
ILYLamp, Infrared, Therapeutic Heating222
IRTPad, Heating, Powered22
ILYLamp, infrared, therapeutic heating8
ISAMassager, Therapeutic, Electric4
GZJStimulator, Nerve, Transcutaneous, For Pain Relief3
JFBTable, Physical Therapy, Multi Function2

GMDN & GCC registration

  • GMDN code 35147 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 24% · OTC 49%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Pound) · 16Width (Inch) · 11Length (Inch) · 6Weight (Kilogram) · 4Height (Inch) · 4

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

How many musculoskeletal infrared phototherapy unit, non-wearable products are registered in the US?

237 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Musculoskeletal infrared phototherapy unit, non-wearable", from 35 companies. The largest labeler is Healthlight Llc with 26% of records.

Which FDA product codes apply?

ILY (Lamp, Infrared, Therapeutic Heating), IRT (Pad, Heating, Powered), ILY (Lamp, infrared, therapeutic heating), ISA (Massager, Therapeutic, Electric)

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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