Cleared Traditional

Iontophoresis Electrodes

K232020 · Top-Rank Health Care Co., Ltd. · Physical Medicine

Oct 2023

Decision

101d

Days

Class 2

Risk

About This 510(k) Submission

K232020 is an FDA 510(k) clearance for the Iontophoresis Electrodes, a Device, Iontophoresis, Other Uses (Class II — Special Controls, product code EGJ), submitted by Top-Rank Health Care Co., Ltd. (Shaoxing, CN). The FDA issued a Cleared decision on October 16, 2023, 101 days after receiving the submission on July 7, 2023. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5525.

Submission Details

510(k) Number	K232020 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 2023
Decision Date	October 16, 2023
Days to Decision	101 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF