Cleared Traditional

Conductive Gel

K221724 · Tone-A-Matic International, Inc. · Neurology
Sep 2022
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K221724 is an FDA 510(k) clearance for the Conductive Gel, a Media, Electroconductive (Class II — Special Controls, product code GYB), submitted by Tone-A-Matic International, Inc. (Mississauga, CA). The FDA issued a Cleared decision on September 23, 2022, 101 days after receiving the submission on June 14, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1275.

Submission Details

510(k) Number K221724 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 2022
Decision Date September 23, 2022
Days to Decision 101 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code GYB — Media, Electroconductive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1275