# K152021: Pure Tilt

- Pathway: 510(k) (Traditional)
- Applicant: Proactive Comfort, LLC
- Decided: Mar 31, 2016 after 254 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: 9 generations back to K020472 (2002). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032133: Broda Model 587 Manual Wheelchair, Broda Ent., Inc. (2003) Summary page 5.
- K130017: Valentine Steel Wheelchair, Valentine Intl., Ltd. (2014) Summary page 6.

## Indications for use
The Pure Tilt™ wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Source page: https://510kreport.com/device/K152021
Methodology: https://510kreport.com/methodology