Cleared Traditional

K221199 - Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) (FDA 510(k) Clearance)

K221199 · Green Island International Tcm Group Limited · Neurology device

Dec 2023

Decision

602d

Days

Class 2

Risk

K221199 is an FDA 510(k) clearance for the Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode). This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).

Submitted by Green Island International Tcm Group Limited (Hongkong, CN). The FDA issued a Cleared decision on December 19, 2023, 602 days after receiving the submission on April 26, 2022.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number	K221199 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 26, 2022
Decision Date	December 19, 2023
Days to Decision	602 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Statement