Class Class II
EZ-STIK Electrodes (K223775)
Description
EZ-STIK Electrodes by South Dakota Partners, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223775
Clearance Date2023-01-03
Clearance TypeTraditional
Product CodeGXY
Regulation Number882.1320
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223775
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. EZ-STIK Electrodes (K223775) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K160138 | Adhesive Electrodes | Gmdasz Manufacturing Co., Ltd. | 2016 |
| K050469 | EZ-STIK ELECTRODES | Naimco, Inc. | 2005 |
Trace the full predicate network for K223775
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.