Transcutaneous Electrical Nerve Stimulator (K6106) (K241119)
Description
Transcutaneous Electrical Nerve Stimulator (K6106) by Shenzhen Yicai Health Technology Co., Ltd., an FDA 510(k) cleared neurology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241119
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. Transcutaneous Electrical Nerve Stimulator (K6106) (K241119) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201354 | TENS & PMS | Hong Qiangxing (Shenzhen) Electroni... | 2020 |
| K192264 | HIVOX Spopad EMS SP-911, SP-921 | Hivox Biotek, Inc. | 2019 |
| K191151 | JKH Stimulator Plus | Jkh USA, LLC | 2019 |
| K171803 | HIVOX OTC Electrical Stimulator | Hivox Biotek, Inc. | 2017 |
Trace the full predicate network for K241119
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.