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 transport wheelchair, collapsible FDA UDI
Device Name: Stainless Steel 20" seat width - transport chair, 12-1/2" rear wheels, 300lb. capacity,less front rigging, Burgandy, FDA UDI
Model / Reference: WCM2025NF27 FDA UDI
Description: Stainless Steel 20" seat width - transport chair, 12-1/2" rear wheels, 300lb. capacity,less front rigging, Burgandy, FDA UDI

Identifiers

Primary DI / UDI-DI: 00854362008316 FDA UDI
510(k) Number: K973418 FDA UDI
FDA Product Code: IOR FDA UDI
GMDN Term: Bariatric transport wheelchair, 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Bariatric transport wheelchair, collapsible

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

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Cleared under the same submission

K973418 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Assembly Required Distributors Inc

Sources (1)

FDA UDI e7d4e186-aa2a-46b5-9891-831e1648a89f 34 fields · synced May 30, 2026