DREAM FACTORY INC.

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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) (3)

Premarket Exempt

Yes

Clear

TB12 VIBRATING PLIABILITY ROLLER - 04580657301003 Catalog Number :

Device Description : Offers people of all ages, gender and abilities the benefits to improve the body Offers people of all ages, gender and abilities the benefits to improve the body’s overall performance, flexibility, and range of motion to prevent injury and thus improve overall well being.

Device Class : 1

Duns Number: 698505802

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

TB12 VIBRATING PLIABILITY SPHERE - 04580657301010 Catalog Number :

Device Class : 1

Duns Number: 698505802

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

TB12 VIBRATING PLIABILITY MINI SPHERE - 04580657301027 Catalog Number :

Device Class : 1

Duns Number: 698505802

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

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