Class Class II
eFOLDi Navigator Powerchair (STPC-A) (K243110)
Description
eFOLDi Navigator Powerchair (STPC-A) by Suntech UK , Ltd., an FDA 510(k) cleared physical medicine device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243110
Clearance Date2025-05-08
Clearance TypeTraditional
Product CodeITI
Regulation Number890.3860
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243110
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. eFOLDi Navigator Powerchair (STPC-A) (K243110) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232121 | Power wheelchair (Model:BC-EA8000) | Ningbo Baichen Medical Devices Co.,... | 2023 |
Trace the full predicate network for K243110
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.