FDA.reportPublic FDA data

3H

Primary DI
08809524496595
Brand
3H
Company
3H, Co., Ltd
Model
3H-2030 S12
Published
2025-05-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
08809524496595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809524496595088095244965958809524496595

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+8201049467582jjs0612@3hk.co.kr

Regulatory Flags#

DUNS number
690390383
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

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
088095244977693H Heating Belt3h-1370 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
088095244966703H3H-780 S122025-05-30
088095244966943HSD-820 SJ-S-052025-05-30
088095244967003H3H-820-052025-05-30
088095244967173H3H-820-S-052025-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00622356753760Shark™ FacialPro Glow™SharkNinja Operating LLCIRT2026-08-17
00622356753937Shark™ FacialPro Glow™SharkNinja Operating LLCIRT2026-08-17
00622356759533Shark™ FacialPro Glow™SharkNinja Operating LLCIRT2026-08-17
00040337006559ThermophoreBattle Creek Equipment Co.IRT2026-08-07
088095244977693H Heating Belt3H, Co., LtdIRT2026-07-29
088095244977763H Abdomen Fomentation Device3H, Co., LtdIRT2026-07-29
088095244977833H Abdomen Fomentation Device3H, Co., LtdIRT2026-07-29
00671152103873Bug Bite Relief PenJc & A Canada Inc.IRT2026-07-16
00671152104788Bug Bite Relief PenJc & A Canada Inc.IRT2026-07-16
00810140063052RenphoJoicom CorporationIRT2026-06-23
00810140063069RenphoJoicom CorporationIRT2026-06-23
08809851470145WavefacialWEERO Co., Ltd.IRT2026-06-22
00810110200562BeurerBEURER NORTH AMERICA, L.P.IRT2026-06-09
00850087490177AMOOSChangsha Yuhong Trading Co., LtdIRT2026-06-09
00850087490184AMOOSChangsha Yuhong Trading Co., LtdIRT2026-06-09
00041298995326DMID-M-S HOLDINGS, INC.IRT2026-06-05
00622356691161Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356699631Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356703048Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356704885Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356704953Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356710664Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356710718Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356712200Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356736633Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00840295411637TherabodyTherabody, Inc.IRT2026-06-01
09413000135374Flowpresso Compression DeviceMEDELLA HEALTH LIMITEDIRT2025-10-16
00031262116291HomedicsHuizhou XINYI Technology Co., LTDIRT2025-02-01
00031262116697HomedicsHuizhou XINYI Technology Co., LTDIRT2025-01-01
00031262116666HomedicsHuizhou XINYI Technology Co., LTDIRT2024-12-31