# K123975: Quickie & Zippie Series

- Pathway: 510(k) (Traditional)
- Applicant: Sunrise Medical
- Decided: Aug 16, 2013 after 233 days
- Product code: IOR (Wheelchair, Mechanical)
- Device class: 1
- Regulation: 21 CFR 890.3850
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K161425: APEX Manual Wheelchair (2016), 3 descendants of its own
- K243111: Bowhead ERA Wheelchairs (2025), 1 descendant of its own
- K143101: Helio A7 Manual Wheelchair, Move Manual Wheelchair (2015), 1 descendant of its own
- K260295: Helio Kids; Apex P (2026), 0 descendants of its own
- K260121: Manual Wheelchair (7101L, 7102LHD) (2026), 0 descendants of its own

## Recalls of this device
- Jul 1, 2016 · Class II · Z-2290-2016: 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 de
- Jul 27, 2015 · Class II · Z-2467-2015: 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.
- Jul 27, 2015 · Class II · Z-2466-2015: 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.
- Dec 19, 2014 · Class II · Z-1020-2015: There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs.
- Nov 11, 2013 · Class II · Z-0453-2014: 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 th

## Indications for use
The Sunrise Medical Zippie and Quickie Series Wheelchairs are intended to provide mobility to persons limited to a sitting position.

Source page: https://510kreport.com/device/K123975
Methodology: https://510kreport.com/methodology