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Quickie & Zippie Series

by Sunrise Medical 510(k)

Active United States

510(k) K123975

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK123975 Date16 Aug 2013ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

5 recalls · FDA

    • Terminated Z-2290-2016 FDA Class II initiated 1 Jul 2016

    There is an observed failure of the backrest bracket which can fatigue over the life time of the product. When this occurs there is the possibility of the bracket fracturing causing the backrest to detach from the chair frame.

  • 2 recalls, same reason

    • Terminated Z-2467-2015 FDA Class II initiated 27 Jul 2015
    • Terminated Z-2466-2015 FDA Class II initiated 27 Jul 2015

    Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant.

    • Terminated Z-1020-2015 FDA Class II initiated 19 Dec 2014

    There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs.

    • Terminated Z-0453-2014 FDA Class II initiated 11 Nov 2013

    There is a remote possibility for the plastic latch to deform over the lifetime of use. When this happens there is the possibility for the seat to become dislodged from the base. And when not using the positioning strap, there is a risk that the occupant could slide out of the seat and sustain injury.

Specification

510(k)

510(k) Number
FDA Product Code
IOR
Device Class
Class I
Regulation
21 CFR Part 890.3850
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

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