# K031618: Comfort Various of Standing Wheelchair, Hero 2

- Pathway: 510(k) (Traditional)
- Applicant: Comfort Orthopedic Co., Ltd.
- Decided: Dec 18, 2003 after 209 days
- Product code: IPL (Wheelchair, Standup)
- Device class: 2
- Regulation: 21 CFR 890.3900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K102734: Comfort Standing Wheelchair, Hero Series (2010), 0 descendants of its own

## Indications for use
The device is a product which changes people position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility. For all individuals who need a standing Wheelchair with the possibility to change positions and who can not stand on their feet themselves such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..

Source page: https://510kreport.com/device/K031618
Methodology: https://510kreport.com/methodology