# K243111: Bowhead ERA Wheelchairs

- Pathway: 510(k) (Traditional)
- Applicant: Bowhead Design Corp.
- Decided: Jan 10, 2025 after 102 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: 5 generations back to K922535 (1992). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161425: APEX Manual Wheelchair, Motion Composites (2016) Summary page 5.
- K220698: Bambino 3, S3 and S3 Swing, U3 and U3 Light, X, Panthera AB (2023) Summary page 5.

## Most influential descendants
- K260121: Manual Wheelchair (7101L, 7102LHD) (2026), 0 descendants of its own

## Indications for use
The Bowhead ERA Wheelchairs are manually operated wheelchairs intended to be used as a means of mobility for individuals restricted to a sitting position.

Source page: https://510kreport.com/device/K243111
Methodology: https://510kreport.com/methodology