Class Class II
Electrically Powered Wheelchair (K243962)
Description
Electrically Powered Wheelchair by Kunshan Hi-Fortune Health Products Co., Ltd., an FDA 510(k) cleared physical medicine device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243962
Clearance Date2025-02-12
Clearance TypeSpecial
Product CodeITI
Regulation Number890.3860
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243962
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. Electrically Powered Wheelchair (K243962) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212503 | HP458E Electrically Powered Wheelchair | Kunshan Hi-Fortune Health Products ... | 2022 |
Trace the full predicate network for K243962
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.