Cleared Traditional

Self-adhesive Electrode

K213879 · Bozhou Rongjian Medical Appliance Co., Ltd. · Neurology
Jan 2022
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K213879 is an FDA 510(k) clearance for the Self-adhesive Electrode, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Bozhou Rongjian Medical Appliance Co., Ltd. (Bozhou, CN). The FDA issued a Cleared decision on January 5, 2022, 23 days after receiving the submission on December 13, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K213879 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2021
Decision Date January 05, 2022
Days to Decision 23 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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