FDA.reportPublic FDA data

Therabody

Primary DI
00840295401874
Brand
Therabody
Company
Therabody, Inc.
Model
Theragun PRO PLUS
Device description
Hand Held Massager
Published
2023-11-07
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
ILYLamp, Infrared, Therapeutic Heating
IMEPack, Hot Or Cold, Reusable
IRTPad, Heating, Powered
ISAMassager, Therapeutic, Electric
PGJOximeter, Wellness

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2
IMEPack, Hot Or Cold, ReusablePhysical Medicine1
IRTPad, Heating, PoweredPhysical Medicine2
ISAMassager, Therapeutic, ElectricPhysical Medicine1
PGJOximeter, WellnessCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840295401874PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840295401874008402954018748402954018740840295401874

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held electric massagerAn electrically-powered device with a vibrating head, or pads, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may optionally be heated, and may be interchangeable with others of different size and shape. It is typically used for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility.

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
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
00810036057035RecoveryAirRecoveryAir PRO Pump2021-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00850087184038HomedicsFKA DISTRIBUTING CO., LLCILY2026-07-13
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00050428167335CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDPGJ2026-07-10
00050428167342CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDPGJ2026-07-10
00810140063052RenphoJoicom CorporationIRT2026-06-23
00810140063069RenphoJoicom CorporationIRT2026-06-23
00810140063076RenphoJoicom CorporationISA2026-06-23
08800291820323HEALITE IICynosure Lutronic Technology CorporationILY2026-06-23
08809851470145WavefacialWEERO Co., Ltd.IRT2026-06-22
06972433811246JermeiShenzhen Jermei Medical Device Technology Co.,LtdISA2026-06-10
00049696508339THERA PlusFOURSTAR GROUP INC.IME2026-06-09
00049696508346B.PUREFOURSTAR GROUP INC.IME2026-06-09
00050428299838CVSHealthFOURSTAR GROUP INC.IME2026-06-09
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
00850071298017Smart-RSTHyperion Medical Technologies, Inc.ISA2026-06-02
00840295411637TherabodyTherabody, Inc.IRT2026-06-01
00840295411637TherabodyTherabody, Inc.IME2026-06-01
00860179001013FUSION PBM Plus LightDentlight Inc.ILY2026-05-27