FDA.reportPublic FDA data

Therabody

Primary DI
00810036059862
Brand
Therabody
Company
Therabody, Inc.
Model
TheraCup
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
KNMDevice, Pressure Applying

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNMDevice, Pressure ApplyingPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810036059862PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810036059862008100360598628100360598620810036059862

GMDN Terms#

Term, Definition table
TermDefinition
Acupressure applicator, reusableA small device intended for the application of noninvasive, non-powered acupressure to acupuncture points on the skin for the treatment of a variety of conditions/disorders. It is made of polymer materials and is supplied in a variety of shapes and sizes with differently shaped contact points; it is typically held on the skin with slight manual pressure. This is a reusable device.

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
04547248600020SEIRIN ShonishinSEIRIN CORPORATIONKNM2026-05-31
10885632465031HalyardOWENS & MINOR DISTRIBUTION, INC.KNM2026-01-22
20885632465038HalyardOWENS & MINOR DISTRIBUTION, INC.KNM2026-01-22
00818318025352iCare Vacuum Cupping SetPrime Holly CorporationKNM2025-05-16
10818318029081iCare Vacuum Cupping SetPrime Holly CorporationKNM2025-05-16
04547248423056SEIRIN PY-ZeroSEIRIN CORPORATIONKNM2025-03-03
04547248423063SEIRIN PY-ZeroSEIRIN CORPORATIONKNM2025-03-03
14547248423053SEIRIN PY-ZeroSEIRIN CORPORATIONKNM2025-03-03
24547248423067SEIRIN PY-ZeroSEIRIN CORPORATIONKNM2025-03-03
06977182810113Shenzhen Wells Optoelectronics Co.,Ltd.Shenzhen Wells Optoelectronics Co.,Ltd.KNM2024-06-16
03760262490625BAT02 Glass rodsSEDATELECKNM2024-04-25
03760262490670EASYO 1 - Multi Pressure FeelerSEDATELECKNM2024-04-25
03760262492902PAL130 Pressure feeler 130gSEDATELECKNM2024-04-25
03760262492919PAL250 Pressure feeler 250gSEDATELECKNM2024-04-25
03760262492926PAL400 Pressure feeler 400gSEDATELECKNM2024-04-25
03760262492933PAL650 Pressure feeler 650gSEDATELECKNM2024-04-25
07350120791955KIWI DermaForeo ABKNM2024-03-11
06901452150005HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
06901452150012HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
06901452150029HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
06901452150050HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
06901452150067HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
06901452150074HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
06901452150081HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
16901452983860HWATO Vaccaria seed W/P-50, with TapeSuzhou Medical Appliance FactoryKNM2023-10-10
36901452983864HWATO Vaccaria seed W/P-50, with TapeSuzhou Medical Appliance FactoryKNM2023-10-10
00840252904004Sensory VestTherafin CorporationKNM2023-07-06
00840252904011Sensory VestTherafin CorporationKNM2023-07-06
00840252904028Sensory VestTherafin CorporationKNM2023-07-06
00840252904035Sensory VestTherafin CorporationKNM2023-07-06