DYNAREX CORPORATION

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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

Walker, Mechanical (ITJ) (10)

Premarket Exempt

No Yes

Clear

DynaGo Quad 6 - (Red) Aluminum Rollator with 6" Wheels - 00616784020143 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : ITJ

Prescription Use : No

Device Count : 1

DynaGo Quad 8 - Aluminum Rollator with 7.5" Wheels - 00616784020211 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : ITJ

Prescription Use : No

Device Count : 1

Bariatric Rollator - 00616784020310 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : ITJ

Prescription Use : No

Device Count : 1

DynaGo Flex - Adjustable Seat Height w Detachable Caster - 00616784020419 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : ITJ

Prescription Use : No

Device Count : 1

DynaGo Advantage - Steel Rollator with 6" Wheels, Red - 00616784020518 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : ITJ

Prescription Use : No

Device Count : 1

DynaGo Advantage - Steel Rollator with 6" Wheels, Blue - 00616784020617 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : ITJ

Prescription Use : No

Device Count : 1

DynaGo Duo Rollator - 00616784020815 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : ITJ

Prescription Use : No

Device Count : 1

Bariatric Rollator - 00616784020914 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : ITJ

Prescription Use : No

Device Count : 1

Steerable Knee Walker with Basket - Compact - 00616784021515 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : ITJ

Prescription Use : No

Device Count : 1

Steerable Knee Walker with Basket - 00616784021614 Catalog Number :

Device Class : 1

Duns Number: 008124539

Premarket Exempt : Yes

Product Code : ITJ

Prescription Use : No

Device Count : 1

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