Class Class II
Myolift QT (K213078)
Description
Myolift QT by Johari Digital Healthcare Limited, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK213078
Clearance Date2023-04-27
Clearance TypeTraditional
Product CodeNFO
Regulation Number882.5890
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K213078
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. Myolift QT (K213078) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212342 | ZIIP+ Device | Ziip, Inc. | 2021 |
Trace the full predicate network for K213078
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.