FDA.reportPublic FDA data

Therabody

Primary DI
00840295401959
Brand
Therabody
Company
Therabody, Inc.
Model
Theragun SENSE
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
ISAMassager, Therapeutic, Electric
PGJOximeter, Wellness

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1
PGJOximeter, WellnessCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840295401959PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840295401959008402954019598402954019590840295401959

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07630039101855MASTERPULS®Storz Medical AGISA2026-04-15
00786585793505SEJOYJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-28
00045915831424Human TouchHuman Touch, LLCISA2026-01-12
00045915831431Human TouchHuman Touch, LLCISA2026-01-12
00045915831448Human TouchHuman Touch, LLCISA2026-01-12
00045915831455Human TouchHuman Touch, LLCISA2026-01-12
00045915831462Human TouchHuman Touch, LLCISA2026-01-12
00045915831479Human TouchHuman Touch, LLCISA2026-01-12
00045915831486Human TouchHuman Touch, LLCISA2026-01-12
00045915831493Human TouchHuman Touch, LLCISA2026-01-12
08034108512679Plus HandpieceDEKA M.E.L.A. SRLISA2025-10-22
00197344153605MEDLINEMEDLINE INDUSTRIES, INC.ISA2025-10-17
00050428168721CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDPGJ2025-09-30
00050428168738CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDPGJ2025-09-30
08800205600003NeuclareDeepsonbio Co., LtdISA2025-08-08
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.ISA2025-07-15
00311917054537WalgreensWALGREEN CO.PGJ2024-11-29
00810140061355RENPHOJoicom CorporationISA2024-11-19
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00810140061379RENPHOJoicom CorporationISA2024-11-19
00810140061386RENPHOJoicom CorporationISA2024-11-19
00074108453488CONAIRCONAIR CORPORATIONISA2024-10-07
00682891216021ZewaVERIDIAN HEALTHCARE LLCPGJ2024-06-21
00810140060501RENPHO EyeSpa MistJoicom CorporationISA2023-08-08
00810140060518RENPHO EyeSnooze Sleep MaskJoicom CorporationISA2023-08-08
00810140060525RENPHO Ice Head WrapJoicom CorporationISA2023-08-08
00810140060532RENPHO Eye Spa PodsJoicom CorporationISA2023-08-08
00810140060778RENPHO EyeSnooze Sleep MaskJoicom CorporationISA2023-08-08