FDA.reportPublic FDA data

3H Heating Belt

Primary DI
08809524497769
Brand
3H Heating Belt
Company
3H, Co., Ltd
Model
3h-1370 US
Published
2026-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809524497769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809524497769088095244977698809524497769

GMDN Terms#

Term, Definition table
TermDefinition
Electric pad localized-body heating systemAn assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is intended for use in the home or a clinical setting.

Regulatory Flags#

DUNS number
690390383
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
088095244976843H Smart Massage Bed3H-820WD US2026-07-29
088095244976913H Smart Massage BedSA-820R US2026-07-29
088095244977073H Smart Massage BedSD-820SJ US2026-07-29
088095244977143H Smart Massage Bed3H-920C US2026-07-29
088095244977213H Smart Massage Bed3H-920CV US2026-07-29
088095244977383H Smart Massage Bed3H-1300N US2026-07-29
088095244977453H Smart Massage Bed3H-1300WD US2026-07-29
088095244977523H Smart Massage Bed3H-1530K US2026-07-29
088095244977763H Abdomen Fomentation Device3H-780 US2026-07-29
088095244977833H Abdomen Fomentation Device3H-2030 US2026-07-29
088095244976773H Smart Massage Bed3H-820 US2026-07-28
088095244971583HSD-820 SJ-052025-06-12
088095244966873H3H-820 SJ-052025-05-30
088095244969393H3H-820 N-S-052025-05-30
088095244965333H3h-1370 S122025-05-30
088095244965953H3H-2030 S122025-05-30
088095244966703H3H-780 S122025-05-30
088095244966943HSD-820 SJ-S-052025-05-30
088095244967003H3H-820-052025-05-30
088095244967173H3H-820-S-052025-05-30

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