N.Y. ORTHOPEDIC USA, INC.

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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

Cushion, Wheelchair (IMP) (3)

Premarket Exempt

Yes

Clear

NYOrtho APEX Wheelchair Cushion Gel-Foam 18x16x3 - 00811677011745 Catalog Number :

Device Description : The NYOrtho APEX Gel-Foam Cushion features an innovative design that chambers th

Device Class : 1

Duns Number: 612083873

Premarket Exempt : Yes

Product Code : IMP

Prescription Use : No

Device Count : 1

NYOrtho Wheelchair Cushion Gel-Foam 18x16x3 - 00811677011769 Catalog Number :

Device Description : NYOrtho Gel-Foam Cushions combine a dual chambered gel insert within a dual dens

Device Class : 1

Duns Number: 612083873

Premarket Exempt : Yes

Product Code : IMP

Prescription Use : No

Device Count : 1

NYOrtho APEX CORE Wheelchair Cushion Gel-Foam 18x16x3 - 00811677015699 Catalog Number :

Device Description : The NYOrtho APEX CORE Gel-Foam Cushion combines a firm core foundation that elim

Device Class : 1

Duns Number: 612083873

Premarket Exempt : Yes

Product Code : IMP

Prescription Use : No

Device Count : 1

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