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Assembly Required Distributors WCM2226LS50

by Assembly Required Distributors Inc

Assembly Required Distributors WCM2226LS50 is a bariatric wheelchair (FDA Class I; FDA product code IOR, Wheelchair, Mechanical) made by Assembly Required Distributors Inc, cleared under FDA 510(k) K973418 on 9 Oct 1997 and listed in FDA GUDID since 23 Apr 2018 (UDI-DI 00854362008347), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K973418

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00854362008347 UDI-DI Date23 Apr 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK973418 Date9 Oct 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K973418 decided 9 Oct 1997 Active
  • FDA GUDID UDI-DI 00854362008347 listed 23 Apr 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K973418
  2. Listed FDA GUDID 00854362008347

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Assembly Required Distributors
Generic name
Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
Model / reference
WCM2226LS50
Description
Stainless steel W/C, 22" width, 350 lb. cap, rem desk length arm, green, w/ seat belt no front rigging
Primary DI / UDI-DI
00854362008347
510(k) Number
FDA product code
IOR
GMDN term
Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
Device class
Class I
Regulation number
890.3850
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Similar devices

Other devices filed under FDA product code IOR (Wheelchair, Mechanical).

Other devices from Assembly Required Distributors Inc

See all devices from Assembly Required Distributors Inc →

Properties

  • Lot / batch number
  • Serial number
Other properties (13, all answered No)