Comfytopia, Inc.

Address:48511 WARM SPRINGS BLVD STE 213,,Fremont,CA,94539,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

Band Or Belt, Pelvic Support (ISR) (9) Orthosis, Truncal/Orthosis, Limb (MRI) (1)

Premarket Exempt

Yes

Clear

Comfytopia - 04719879640922 Catalog Number :

Device Description : WB30 Wrist Fulcrum Wrap Orth Ergo Cushion Splint

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : MRI

Prescription Use : No

Device Count : 1

Comfytopia - 04719879641486 Catalog Number :

Device Description : BS33 Low Back Fulcrum Wrap Easyfit w/Splint

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : ISR

Prescription Use : No

Device Count : 1

Comfytopia - 04719879641516 Catalog Number :

Device Description : BS34 Upper Back Fulcrum Wrap Ergonomic Splint

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : ISR

Prescription Use : No

Device Count : 1

Comfytopia - 04719879641608 Catalog Number :

Device Description : BP31 Low Back Fulcrum Wrap Ergo Stabilizing Splint Gray S-size

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : ISR

Prescription Use : No

Device Count : 1

Comfytopia - 04719879641615 Catalog Number :

Device Description : BP31 Low Back Fulcrum Wrap Ergo Stabilizing Splint Gray M-size

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : ISR

Prescription Use : No

Device Count : 1

Comfytopia - 04719879641622 Catalog Number :

Device Description : BP31 Low Back Fulcrum Wrap Ergo Stabilizing Splint Gray L-size

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : ISR

Prescription Use : No

Device Count : 1

Comfytopia - 04719879641684 Catalog Number :

Device Description : BP30 Low Back Fulcrum Wrap Ergo stabilizing Splint BlackS-size

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : ISR

Prescription Use : No

Device Count : 1

Comfytopia - 04719879641691 Catalog Number :

Device Description : BP30 Low Back Fulcrum Wrap Ergo stabilizing Splint BlackM-size

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : ISR

Prescription Use : No

Device Count : 1

Comfytopia - 04719879641707 Catalog Number :

Device Description : BP30 Low Back Fulcrum Wrap Ergo stabilizing Splint BlackL-size

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : ISR

Prescription Use : No

Device Count : 1

Comfytopia - 04719879641950 Catalog Number :

Device Description : MS60 Maternity Belt Fulcrum Wrap Comfy & Ultrasoft Black

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : ISR

Prescription Use : No

Device Count : 1

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