Theragun, Inc

Address:10407 Centurion Pkwy N,Jacksonville,FL,32256,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Massager, Powered Inflatable Tube (IRP) (5) Light Based Over The Counter Wrinkle Reduction (OHS) (2) Over-The-Counter Powered Light Based Laser For Acne (OLP) (2) Pack, Hot Or Cold, Reusable (IME) (2) Pad, Heating, Powered (IRT) (2) Vibrator, Therapeutic (IRO) (2) Lamp, Infrared, Therapeutic Heating (ILY) (2) Stimulator, Transcutaneous Electrical, Aesthetic Purposes (NFO) (2) Stimulator, Muscle, Powered, For Muscle Conditioning (NGX) (1)

Premarket Exempt

No Yes

Clear

PowerDot - 00810036056175 Catalog Number :

Device Class : 2

Duns Number: 080550811

Premarket Exempt : No

Product Code : NGX

Prescription Use : No

Device Count : 1

RecoveryAir - 00810036056229 Catalog Number :

Device Description : Powered inflatable tube massager

Device Class : 2

Duns Number: 080550811

Premarket Exempt : No

Product Code : IRP

Prescription Use : No

Device Count : 1

TheraFace - 00810036056687 Catalog Number :

Device Description : The TheraFace PRO is a 4-in-1 handheld device that takes facial wellness to the The TheraFace PRO is a 4-in-1 handheld device that takes facial wellness to the next level by helping to reduce tension, relax facial muscles, and achieve healthier-looking skin by gently stimulating the face. It includes microcurrent, blue, red, and red+infrared light LED, and cleansing treatments, allowing you to customize your facial therapy in one easy-to-use versatile device. Use the variety of treatment rings to help lift, tone, rejuvenate, and deep clean.

Device Class : 1

Duns Number: 080550811

Premarket Exempt : No

Product Code : ILY, IRO, NFO, OHS, OLP

Prescription Use : No

Device Count : 1

TheraFace - 00810036056724 Catalog Number :

Device Class : 1

Duns Number: 080550811

Premarket Exempt : No

Product Code : ILY, IRO, NFO, OHS, OLP

Prescription Use : No

Device Count : 1

TheraFace - 00810036056762 Catalog Number :

Device Class : 1

Duns Number: 080550811

Premarket Exempt : Yes

Product Code : IRT, IME

Prescription Use : No

Device Count : 1

TheraFace - 00810036056809 Catalog Number :

Device Class : 1

Duns Number: 080550811

Premarket Exempt : Yes

Product Code : IME, IRT

Prescription Use : No

Device Count : 1

RecoveryAir - 00810036056908 Catalog Number :

Device Description : Powered inflatable tube massager

Device Class : 2

Duns Number: 080550811

Premarket Exempt : No

Product Code : IRP

Prescription Use : No

Device Count : 1

RecoveryAir - 00810036056946 Catalog Number :

Device Description : Powered inflatable tube massager

Device Class : 2

Duns Number: 080550811

Premarket Exempt : No

Product Code : IRP

Prescription Use : No

Device Count : 1

RecoveryAir - 00810036056984 Catalog Number :

Device Description : Powered inflatable tube massager

Device Class : 2

Duns Number: 080550811

Premarket Exempt : No

Product Code : IRP

Prescription Use : No

Device Count : 1

RecoveryAir - 00810036057035 Catalog Number :

Device Description : Powered inflatable tube massager

Device Class : 2

Duns Number: 080550811

Premarket Exempt : No

Product Code : IRP

Prescription Use : No

Device Count : 1

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