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, Therapeutic, Electric (ISA) (8) Electrode, Cutaneous (GXY) (1) Stimulator, Muscle, Powered, For Muscle Conditioning (NGX) (1)

Premarket Exempt

No Yes

Clear

Theragun - 00810036050135 Catalog Number :

Device Description : Hand held massager

Device Class : 1

Duns Number: 080550811

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

Theragun - 00810036050142 Catalog Number :

Device Class : 1

Duns Number: 080550811

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

Theragun - 00810036050159 Catalog Number :

Device Class : 1

Duns Number: 080550811

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

Theragun - 00810036050166 Catalog Number :

Device Class : 1

Duns Number: 080550811

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

Theragun - 00810036050197 Catalog Number :

Device Description : Elite White

Device Class : 1

Duns Number: 080550811

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

Theragun - 00810036051217 Catalog Number :

Device Class : 1

Duns Number: 080550811

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

Theragun - 00810036054676 Catalog Number :

Device Class : 1

Duns Number: 080550811

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

Theragun - 00810036055116 Catalog Number :

Device Class : 1

Duns Number: 080550811

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

PowerDot - 00810036056151 Catalog Number :

Device Class : 2

Duns Number: 080550811

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

PowerDot - 00810036056168 Catalog Number :

Device Class : 2

Duns Number: 080550811

Premarket Exempt : No

Product Code : NGX

Prescription Use : No

Device Count : 1

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