ASSEMBLY REQUIRED DISTRIBUTORS INC

Address:169 Commack Rd Ste H345,Commack,NY,11725,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

Footrest, Wheelchair (IMM) (5) Walker, Mechanical (ITJ) (3) Cushion, Wheelchair (IMP) (1) Stretcher, Wheeled (FPO) (1)

Premarket Exempt

No Yes

Clear

Assembly Required Distributors - 00854362008002 Catalog Number :

Device Description : IV Pole - all aluminum for Folding Stretcher

Device Class : 2

Duns Number: 170562396

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

Assembly Required Distributors - 00854362008026 Catalog Number :

Device Description : Walker - folding Adult--Spec: W:18", depth: 17", adj height: 32"-36"

Device Class : 1

Duns Number: 170562396

Premarket Exempt : Yes

Product Code : ITJ

Prescription Use : No

Device Count : 1

Assembly Required Distributors - 00854362008033 Catalog Number :

Device Description : Walker - folding, Junior--Spec: W:18", depth: 17", adj hegiht: 28" - 32"

Device Class : 1

Duns Number: 170562396

Premarket Exempt : Yes

Product Code : ITJ

Prescription Use : No

Device Count : 1

Assembly Required Distributors - 00854362008040 Catalog Number :

Device Description : Walker - folding Bariatric-- Spec: W:27-1/2'', depth: 21'', adj height: 32' - 38-1/2''

Device Class : 1

Duns Number: 170562396

Premarket Exempt : Yes

Product Code : ITJ

Prescription Use : No

Device Count : 1

Assembly Required Distributors - 00854362008057 Catalog Number : 38118LMR

Device Description : S/A FR cam lock, complete for 18" WC - left side

Device Class : 1

Duns Number: 170562396

Premarket Exempt : Yes

Product Code : IMM

Prescription Use : No

Device Count : 1

Assembly Required Distributors - 00854362008064 Catalog Number : 38118RMR

Device Description : S/A FR cam lock, complete for 18" WC - right side

Device Class : 1

Duns Number: 170562396

Premarket Exempt : Yes

Product Code : IMM

Prescription Use : No

Device Count : 1

Assembly Required Distributors - 00854362008071 Catalog Number : 38122LMR

Device Description : S/A FR cam lock, complete for 22" & 24" WC - left side

Device Class : 1

Duns Number: 170562396

Premarket Exempt : Yes

Product Code : IMM

Prescription Use : No

Device Count : 1

Assembly Required Distributors - 00854362008088 Catalog Number : 38122RMR

Device Description : S/A FR cam lock, complete for 22" & 24" WC - right side

Device Class : 1

Duns Number: 170562396

Premarket Exempt : Yes

Product Code : IMM

Prescription Use : No

Device Count : 1

Assembly Required Distributors - 00854362008095 Catalog Number : 38124S27MR

Device Description : 2" Solid seat cushion, w/drop hooks for 24" width chair, burgandy vinyl

Device Class : 1

Duns Number: 170562396

Premarket Exempt : Yes

Product Code : IMP

Prescription Use : No

Device Count : 1

Assembly Required Distributors - 00854362008101 Catalog Number : 38126LMR

Device Description : S/A FR cam lock, complete for 24HD & 26"" WC - left side

Device Class : 1

Duns Number: 170562396

Premarket Exempt : Yes

Product Code : IMM

Prescription Use : No

Device Count : 1

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