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Assembly Required Distributors

FDA UDI

Class I (US FDA UDI)

by Assembly Required Distributors Inc

Identity

Trade Name
Assembly Required Distributors FDA UDI
Generic Name
Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible FDA UDI
Device Name
Alum W/C 24" x 20", 500lb cap, non-foldable frame, burg, flip up arm, w f/r, hard seat FDA UDI
Model / Reference
WCA2425LS27 FDA UDI
Description
Alum W/C 24" x 20", 500lb cap, non-foldable frame, burg, flip up arm, w f/r, hard seat FDA UDI

Identifiers

Primary DI / UDI-DI
00854362008286 FDA UDI
510(k) Number
K973418 FDA UDI
FDA Product Code
IOR FDA UDI
GMDN Term
Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

Assembly Required Distributors by Assembly Required Distributors Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible.

Cleared under the same submission

K973418 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Assembly Required Distributors Inc

Sources (1)

  • FDA UDI f648b90f-3b74-46a3-ba0d-5689c9ce2a29 34 fields · synced May 30, 2026