FDA.reportPublic FDA data

Beyond BodiHeat®

Primary DI
00028373749838
Brand
Beyond BodiHeat®
Company
OKAMOTO USA, INC.
Model
74983
Device description
Disposable heat pad for pain relief, non-medicated, apply over-clothing (3ct pack)
Published
2020-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
IMDPack, Hot Or Cold, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMDPack, Hot Or Cold, DisposablePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00028373749838PrimaryGS10
80028373749834Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00028373749838000283737498380283737498380028373749838
8002837374983480028373749834

GMDN Terms#

Term, Definition table
TermDefinition
Hot/cold therapy pack, single-useA non-sterile 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 sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel, peat) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
175752724
Device count
3
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00028373140116WINK CLOSER140112026-03-11
80028373140105WINK CLOSER140112026-03-11
00028373149997WINK CLOSER149992026-03-06
80028373149993WINK CLOSER149992026-03-06
00028373749104Beyond BodiHeat®749102020-08-26
00028373749821Beyond BodiHeat®749822020-08-26
00028373749845Beyond BodiHeat®749842020-08-26
00028373749883Beyond BodiHeat®749882020-08-26
00028373149980WINK CLOSER149982024-09-06
80028373149986WINK CLOSER149982024-09-06
00028373040034004® ZERO ZERO FOUR® Condoms04003040032016-09-22
00028373040102004® ZERO ZERO FOUR® Condoms04010040102016-09-22
00028373040249004® ZERO ZERO FOUR® Condoms04024040242016-09-22
00028373050033004® ZERO ZERO FOUR® Aloe Condoms05003050032016-09-22
00028373050101004® ZERO ZERO FOUR® Aloe Condoms05010050102016-09-22
00028373050248004® ZERO ZERO FOUR® Aloe Condoms05024050242016-09-22
00028373410127BEYOND SEVEN ® ALOE ENRICHED Condoms41012410122016-09-22
00028373040010004® ZERO ZERO FOUR® Condoms04001040012016-09-22
10028373040031004® ZERO ZERO FOUR® Condoms04003040032016-09-22
10028373040109004® ZERO ZERO FOUR® Condoms04010040102016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00049696561518B.PUREFOURSTAR GROUP INC.IMD2026-06-09
00049696562102B.PUREFOURSTAR GROUP INC.IMD2026-06-09
08436587170522ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-18
08436587170010ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170027ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170065ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170102ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170225ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170232ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170249ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170362ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170386ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170553ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170560ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170577ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170638ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170812ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170843ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170867ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170942ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170966ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170973ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171017ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171031ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171208ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171253ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171284ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171314ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171338ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171352ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15