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) (7) Joint, Knee, External Brace (ITQ) (6) Band Or Belt, Pelvic Support (ISR) (3) Joint, Ankle, External Brace (ITW) (1)

Premarket Exempt

Yes

Clear

Comfytopia - 04719879641967 Catalog Number :

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

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : ISR

Prescription Use : No

Device Count : 1

Comfytopia - 04719879642032 Catalog Number :

Device Description : MS90 Pelvis Belt Fulcrum Wrap Comfy & UltraSoft BeigeS/M-size

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : ISR

Prescription Use : No

Device Count : 1

Comfytopia - 04719879642049 Catalog Number :

Device Description : MS90 Pelvis Belt Fulcrum Wrap Comfy & UltraSoft BeigeL/XL-size

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : ISR

Prescription Use : No

Device Count : 1

Comfytopia - 04719879642391 Catalog Number :

Device Description : KB30 Knee Fulcrum Wrap Dual Splints Stablizer w/Fixation Pad

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : IQI, ITQ

Prescription Use : No

Device Count : 1

Comfytopia - 04719879642490 Catalog Number :

Device Description : KP41 Knee Shielder Sleeve Patented Ergo 3D pad Gray S-size

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : IQI, ITQ

Prescription Use : No

Device Count : 1

Comfytopia - 04719879642506 Catalog Number :

Device Description : KP41 Knee Shielder Sleeve Patented Ergo 3D pad Gray M-size

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : IQI, ITQ

Prescription Use : No

Device Count : 1

Comfytopia - 04719879642513 Catalog Number :

Device Description : KP41 Knee Shielder Sleeve Patented Ergo 3D pad Gray L-size

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : IQI, ITQ

Prescription Use : No

Device Count : 1

Comfytopia - 04719879642520 Catalog Number :

Device Description : KP41 Knee Shielder Sleeve Patented Ergo 3D pad Gray XL-size

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : IQI, ITQ

Prescription Use : No

Device Count : 1

Comfytopia - 04719879642872 Catalog Number :

Device Description : KE92 Knee Fulcrum Sleeve Breathable & 4-way Stretch Lightgrey L-Size

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : IQI, ITW

Prescription Use : No

Device Count : 1

Comfytopia - 04719879643527 Catalog Number :

Device Description : KS10 Knee Fulcrum Wrap Comfort fit Pink

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : IQI, ITQ

Prescription Use : No

Device Count : 1

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