# K260121: Manual Wheelchair (7101L, 7102LHD)

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Nanhai Hongchen Medical Equipment Co., Ltd.
- Decided: Apr 28, 2026 after 103 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: 6 generations back to K922535 (1992). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243111: Bowhead ERA Wheelchairs, Bowhead Design Corp. (2025) Summary page 5.

## Indications for use
The manual wheelchair is a manually operated wheelchair intended to be used as a means of mobility for individuals restricted to a sitting position.

Source page: https://510kreport.com/device/K260121
Methodology: https://510kreport.com/methodology