Class Class II
Magnesium alloy scooter (RS100) (K250533)
Description
Magnesium alloy scooter (RS100) by Taizhou Reach Technology Co., Ltd., an FDA 510(k) cleared physical medicine device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250533
Clearance Date2025-05-14
Clearance TypeTraditional
Product CodeINI
Regulation Number890.3800
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250533
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. Magnesium alloy scooter (RS100) (K250533) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240008 | Mobility Scooter (W3331) | Zhejiang Innuovo Rehabilitation Dev... | 2024 |
Trace the full predicate network for K250533
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.