Class Class II

Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) (K222879)

K222879 2023-01-24 Traditional
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Description

Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) by Wuxi Jiajian Medical Instrument Co., Ltd., an FDA 510(k) cleared neurology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK222879
Clearance Date2023-01-24
Clearance TypeTraditional
Product CodeGZJ
Regulation Number882.5890

Categories

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Predicate lineage for K222879

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 (model: TENS WMPS6-1) (K222879) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K220578Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)Bozhou Rongjian Medical Appliance C...2022
K192568Jiajian Self-Adhesive ElectrodeWuxi Jiajian Medical Instrument Co....2021

Trace the full predicate network for K222879

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.

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