Cleared Special

Jiajian Self-Adhesive Electrode

K192568 · Wuxi Jiajian Medical Instrument Co., Ltd. · Neurology
Feb 2021
Decision
504d
Days
Class 2
Risk

About This 510(k) Submission

K192568 is an FDA 510(k) clearance for the Jiajian Self-Adhesive Electrode, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Wuxi Jiajian Medical Instrument Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on February 3, 2021, 504 days after receiving the submission on September 18, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K192568 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2019
Decision Date February 03, 2021
Days to Decision 504 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXY — Electrode, Cutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1320

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