FDA.reportPublic FDA data

Therabody

Primary DI
00810036059671
Brand
Therabody
Company
Therabody, Inc.
Model
RecoveryTherm Hot/Vibration Back
Published
2022-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810036059671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810036059671008100360596718100360596710810036059671

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

Regulatory Flags#

DUNS number
080550811
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840295411637TherabodyCryoTherm Palm2026-06-01
00840295405391Therabody TheraFace Depuffing Wand2024-06-16
00840295401782Therabody RecoveryTherm Cube2023-11-07
00840295401874Therabody Theragun PRO PLUS2023-11-07
00810036059732TherabodyRecoveryTherm Hot/Cold/Vibration Knee 2022-06-06
00810036056762TheraFaceTheraFace Hot & Cold Rings Black2022-01-18
00810036056809TheraFaceTheraFace Hot & Cold Rings White2022-01-18
00840295408224TherabodyTheraFace Conductive Gel2025-01-26
00840295405568TherabodyJetBoots PRO Plus Short2024-11-08
00840295405575TherabodyJetBoots PRO Plus Regular2024-11-08
00840295405582TherabodyJetBoots PRO Plus Long2024-11-08
00840295405698TherabodyJetBoots Prime Small2024-07-17
00840295405704TherabodyJetBoots Prime Medium2024-07-17
00840295405711TherabodyJetBoots Prime Large2024-07-17
00810036056687TheraFaceTheraFace PRO White2022-01-18
00810036056724TheraFaceTheraFace PRO Black2022-01-18
00810036056229RecoveryAir RecoveryAir JetBoots Small2021-12-23
00810036056908RecoveryAirRecoveryAir JetBoots Medium2021-12-23
00810036056946RecoveryAirRecoveryAir JetBoots Large2021-12-23
00810036056984RecoveryAirRecoveryAir Prime Pump2021-12-23

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00622356753937Shark™ FacialPro Glow™SharkNinja Operating LLCIRT2026-08-17
00622356759533Shark™ FacialPro Glow™SharkNinja Operating LLCIRT2026-08-17
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088095244977693H Heating Belt3H, Co., LtdIRT2026-07-29
088095244977763H Abdomen Fomentation Device3H, Co., LtdIRT2026-07-29
088095244977833H Abdomen Fomentation Device3H, Co., LtdIRT2026-07-29
088095244976773H Smart Massage Bed3H, Co., LtdISA2026-07-28
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00810140063052RenphoJoicom CorporationIRT2026-06-23
00810140063069RenphoJoicom CorporationIRT2026-06-23
00810140063076RenphoJoicom CorporationISA2026-06-23
08809851470145WavefacialWEERO Co., Ltd.IRT2026-06-22
06972433811246JermeiShenzhen Jermei Medical Device Technology Co.,LtdISA2026-06-10
00810110200562BeurerBEURER NORTH AMERICA, L.P.IRT2026-06-09
00850087490177AMOOSChangsha Yuhong Trading Co., LtdIRT2026-06-09
00850087490184AMOOSChangsha Yuhong Trading Co., LtdIRT2026-06-09