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Quickie Freestyle Power Wheelchair, Model G-424

by Sunrise Medical, Inc. 510(k)

Active United States

510(k) K031289

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK031289 Date9 May 2003ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-0518-06 FDA Unclassified (pre-2012) initiated 15 Nov 2005

    While operating the powered wheelchair beyond a specified angle of recline, the wheelchair can travel at an unsafe speed when in this position.

Specification

510(k)

510(k) Number
FDA Product Code
ITI
Device Class
Class II
Regulation
21 CFR Part 890.3860
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

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