Cleared Traditional

SM Electrodes

K183154 · Hong Qiangxing (Shenzhen) Electronics Limited · Neurology
Mar 2019
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K183154 is an FDA 510(k) clearance for the SM Electrodes, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Hong Qiangxing (Shenzhen) Electronics Limited (Shenzhen, CN). The FDA issued a Cleared decision on March 26, 2019, 132 days after receiving the submission on November 14, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K183154 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2018
Decision Date March 26, 2019
Days to Decision 132 days
Submission Type Traditional
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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