Class Class I
Bambino 3, S3 and S3 Swing, U3 and U3 Light, X (K220698)
Description
Bambino 3, S3 and S3 Swing, U3 and U3 Light, X by Panthera AB, an FDA 510(k) cleared physical medicine device.
Regulatory Information
Device ClassClass Class I
510(k) NumberK220698
Clearance Date2023-02-16
Clearance TypeTraditional
Product CodeIOR
Regulation Number890.3850
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K220698
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. Bambino 3, S3 and S3 Swing, U3 and U3 Light, X (K220698) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K161425 | APEX Manual Wheelchair | Motion Composites | 2016 |
| K083231 | PANTHERA MECHANICAL WHEELCHAIR, MODELS S2, U2, BAMBINO, MIC... | Panthera Production AB | 2009 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243111 | Bowhead ERA Wheelchairs | Bowhead Design Corp. | 2025 |
Trace the full predicate network for K220698
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.