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, Limb Brace (IQI) (9) Joint, Ankle, External Brace (ITW) (8) Band Or Belt, Pelvic Support (ISR) (1)

Premarket Exempt

Yes

Clear

Comfytopia - 04719879643909 Catalog Number :

Device Description : FP30 Ankle Fulcrum wrap Black L/XL

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : IQI, ITW

Prescription Use : No

Device Count : 1

Comfytopia - 04719879643923 Catalog Number :

Device Description : FS10 Ankle Fulcrum Wrap Comfort Fit Black L/XL

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : IQI, ITW

Prescription Use : No

Device Count : 1

Comfytopia - 04719879643947 Catalog Number :

Device Description : FS10 Ankle Fulcrum Wrap Comfort Fit Black S/M

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : IQI, ITW

Prescription Use : No

Device Count : 1

Comfytopia - 04719879643961 Catalog Number :

Device Description : FS10 Ankle Fulcrum Wrap Comfort Fit Gray L/XL

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : ITW, IQI

Prescription Use : No

Device Count : 1

Comfytopia - 04719879643978 Catalog Number :

Device Description : FS10 Ankle Fulcrum Wrap Comfort Fit Gray S/M

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : IQI, ITW

Prescription Use : No

Device Count : 1

Comfytopia - 04719879643992 Catalog Number :

Device Description : FS10 Ankle Fulcrum Wrap Comfort Fit Pink L/XL

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : IQI, ITW

Prescription Use : No

Device Count : 1

Comfytopia - 04719879644005 Catalog Number :

Device Description : FS10 Ankle Fulcrum Wrap Comfort fit Pink S/M

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : IQI, ITW

Prescription Use : No

Device Count : 1

Comfytopia - 04719879644012 Catalog Number :

Device Description : KP30 Knee Fulcrum Wrap Ergonomic Stabilizer

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

Comfytopia - 04719879644043 Catalog Number :

Device Description : MS61 Maternity Belt Fulcrum Wrap Easy Fit & Soft Pink

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : ISR

Prescription Use : No

Device Count : 1

Comfytopia - 04719879644128 Catalog Number :

Device Description : FP30 Ankle Fulcrum wrap Black S/M

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : IQI, ITW

Prescription Use : No

Device Count : 1

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