Class Class II
Self-adhesive Electrode (K222252)
Description
Self-adhesive Electrode by Shenzhen Roundwhale Technology Co. , Ltd., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222252
Clearance Date2023-01-19
Clearance TypeTraditional
Product CodeGXY
Regulation Number882.1320
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222252
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. Self-adhesive Electrode (K222252) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K180865 | ZMI Self-Adhesive Electrodes | Zmi Electronics , Ltd. | 2018 |
| K160138 | Adhesive Electrodes | Gmdasz Manufacturing Co., Ltd. | 2016 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223802 | accufit | Mettler Electronics Corporation | 2023 |
Trace the full predicate network for K222252
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.