# K182840: Element Pediatric Wheelchair

- Pathway: 510(k) (Traditional)
- Applicant: Leggero, LLC
- Decided: Apr 29, 2019 after 202 days
- Product code: IOR (Wheelchair, Mechanical)
- Device class: 1
- Regulation: 21 CFR 890.3850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K973673 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973673: Quickie Zippie Series, Quickie Breezy Series, Quick Folding Series, Quickie Rigid Series, Sunrise Medical, Inc. (1997) Summary page 5.

## Indications for use
The Element pediatric wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Source page: https://510kreport.com/device/K182840
Methodology: https://510kreport.com/methodology