Class Class I
Bowhead ERA Wheelchairs (K243111)
Description
Bowhead ERA Wheelchairs by Bowhead Design Corp., an FDA 510(k) cleared physical medicine device.
Regulatory Information
Device ClassClass Class I
510(k) NumberK243111
Clearance Date2025-01-10
Clearance TypeTraditional
Product CodeIOR
Regulation Number890.3850
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243111
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Bowhead ERA Wheelchairs (K243111) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220698 | Bambino 3, S3 and S3 Swing, U3 and U3 Light, X | Panthera AB | 2023 |
| K161425 | APEX Manual Wheelchair | Motion Composites | 2016 |
Trace the full predicate network for K243111
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.