Class Class II
Elvie Stride 2 (K242125)
Description
Elvie Stride 2 by Chiaro Technology, Ltd., an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242125
Clearance Date2024-09-27
Clearance TypeSpecial
Product CodeHGX
Regulation Number884.5160
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242125
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. Elvie Stride 2 (K242125) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210936 | Elvie Stride | Chiaro Technology Limited | 2021 |
Trace the full predicate network for K242125
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.