Class Class II
Navigator (FMNVG15); Navigator XL (FMNVX06) (K240105)
Description
Navigator (FMNVG15); Navigator XL (FMNVX06) by Forcemech International, LLC, an FDA 510(k) cleared physical medicine device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240105
Clearance Date2024-08-29
Clearance TypeTraditional
Product CodeITI
Regulation Number890.3860
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240105
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. Navigator (FMNVG15); Navigator XL (FMNVX06) (K240105) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232193 | Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-... | Yurob Rehabilitation Medical Co., Ltd. | 2023 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K244003 | Electrically powered wheelchair | Kunshan Hi-Fortune Health Products ... | 2025 |
Trace the full predicate network for K240105
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.