Comfytopia, Inc.

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

Joint, Knee, External Brace (ITQ) (5) Orthosis, Truncal/Orthosis, Limb (MRI) (5) Orthosis, Limb Brace (IQI) (1)

Premarket Exempt

Yes

Clear

Comfytopia - 04719879640007 Catalog Number :

Device Description : KP31 Knee Fulcrum Wrap Sponged Ergo Stabilizer

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : IQI, ITQ

Prescription Use : No

Device Count : 1

Comfytopia - 04719879640021 Catalog Number :

Device Description : TE60 Thumb Airy Sleeve Airy & Comfysoft Gray S-size

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : MRI

Prescription Use : No

Device Count : 1

Comfytopia - 04719879640038 Catalog Number :

Device Description : TE60 Thumb Airy Sleeve Airy & Comfysoft Gray M-size

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : MRI

Prescription Use : No

Device Count : 1

Comfytopia - 04719879640045 Catalog Number :

Device Description : TE60 Thumb Airy Sleeve Airy & Comfysoft Gray L-size

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : MRI

Prescription Use : No

Device Count : 1

Comfytopia - 04719879640182 Catalog Number :

Device Description : TP32 Thumb Fulcrum wrap Ergonomic Stabilizer

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : MRI

Prescription Use : No

Device Count : 1

Comfytopia - 04719879640243 Catalog Number :

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

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : ITQ

Prescription Use : No

Device Count : 1

Comfytopia - 04719879640250 Catalog Number :

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

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : ITQ

Prescription Use : No

Device Count : 1

Comfytopia - 04719879640267 Catalog Number :

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

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : ITQ

Prescription Use : No

Device Count : 1

Comfytopia - 04719879640274 Catalog Number :

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

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : ITQ

Prescription Use : No

Device Count : 1

Comfytopia - 04719879640915 Catalog Number :

Device Description : EP41 Tennis Elbow Fulcrum Pro Wrap 3D Ergo EVA Pad

Device Class : 1

Duns Number: 003944628

Premarket Exempt : Yes

Product Code : MRI

Prescription Use : No

Device Count : 1

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