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

Orthosis, Truncal/Orthosis, Limb (MRI) (5) Band Or Belt, Pelvic Support (ISR) (3) Joint, Knee, External Brace (ITQ) (2) Orthosis, Limb Brace (IQI) (2)

Premarket Exempt

Yes

Clear

Comfytopia - 04719879643541 Catalog Number :

Device Description : KS10 Knee Fulcrum Wrap Comfort fit Black

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : IQI, ITQ

Prescription Use : No

Device Count : 1

Comfytopia - 04719879643572 Catalog Number :

Device Description : KS10 Knee Fulcrum Wrap Comfort Fit Gray

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : IQI, ITQ

Prescription Use : No

Device Count : 1

Comfytopia - 04719879643596 Catalog Number :

Device Description : SE20 Waist trimmer wrap Enhancement

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : ISR

Prescription Use : No

Device Count : 1

Comfytopia - 04719879643619 Catalog Number :

Device Description : SE22 Waist trimmer Wrap Comfort Fit Trimmer Black L/XL-size

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : ISR

Prescription Use : No

Device Count : 1

Comfytopia - 04719879643633 Catalog Number :

Device Description : SE22 Waist trimmer Wrap Comfort Fit Trimmer Black S/M-size

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : ISR

Prescription Use : No

Device Count : 1

Comfytopia - 04719879643657 Catalog Number :

Device Description : TP30 Thumb Fulcrum Wrap Ergonomic Splint

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : MRI

Prescription Use : No

Device Count : 1

Comfytopia - 04719879643718 Catalog Number :

Device Description : WP30 Wrist Fulcrum Wrap Ergonomic Cushion Splint

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : MRI

Prescription Use : No

Device Count : 1

Comfytopia - 04719879643824 Catalog Number :

Device Description : EP30 Elbow Fulcrum Wrap Ergonomic Splint

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : MRI

Prescription Use : No

Device Count : 1

Comfytopia - 04719879643848 Catalog Number :

Device Description : EP40 Tennis Elbow Fulcrum Wrap Easy fit w/Cushion PadGray

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : MRI

Prescription Use : No

Device Count : 1

Comfytopia - 04719879643855 Catalog Number :

Device Description : ES10 Elbow Fulcrum Wrap Comfort fit Black

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : MRI

Prescription Use : No

Device Count : 1

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