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) (9) Joint, Knee, External Brace (ITQ) (1) Orthosis, Limb Brace (IQI) (1)

Premarket Exempt

Yes

Clear

Comfytopia - 04719879644173 Catalog Number :

Device Description : SE21 Arm & Thigh Trimmer

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : MRI

Prescription Use : No

Device Count : 1

Comfytopia - 04719879645002 Catalog Number :

Device Description : WS10 Wrist Fulcrum Wrap Easy fit Black

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : MRI

Prescription Use : No

Device Count : 1

Comfytopia - 04719879645019 Catalog Number :

Device Description : WS10 Wrist Fulcrum Wrap Easy fit Gray

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : MRI

Prescription Use : No

Device Count : 1

Comfytopia - 04719879645026 Catalog Number :

Device Description : WS10 Wrist Fulcrum Wrap Easy fit Pink

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : MRI

Prescription Use : No

Device Count : 1

Comfytopia - 04719879645057 Catalog Number :

Device Description : ES10 Elbow Fulcrum Wrap Comfort fit Gary

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : MRI

Prescription Use : No

Device Count : 1

Comfytopia - 04719879645064 Catalog Number :

Device Description : ES10 Elbow Fulcrum Wrap Comfort fit Pink

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : MRI

Prescription Use : No

Device Count : 1

Comfytopia - 04719879645309 Catalog Number :

Device Description : EE91 Elbow Fulcrum Sleeve Breathable & 4-way stretch GrayS-size Pair

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : MRI

Prescription Use : No

Device Count : 1

Comfytopia - 04719879645316 Catalog Number :

Device Description : EE91 Elbow Fulcrum Sleeve Breathable & 4-way stretch GrayM-size Pair

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : MRI

Prescription Use : No

Device Count : 1

Comfytopia - 04719879645323 Catalog Number :

Device Description : EE91 Elbow Fulcrum Sleeve Breathable & 4-way stretch GrayL-size Pair

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : MRI

Prescription Use : No

Device Count : 1

Comfytopia - 04719879645330 Catalog Number :

Device Description : KS91 Knee Fulcrum Sleeve Breathable w/Ergo Cushion pad Lightgrey S-Size Pair

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : ITQ, IQI

Prescription Use : No

Device Count : 1

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