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FDA 510(k)

Iontophoresis Electrodes

K-Number: K232020 · 2023-10-16

Decision Date2023-10-16
Product CodeEGJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Iontophoresis Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Top-Rank Health Care Co., Ltd.. It received FDA 510(k) clearance on 2023-10-16 under 510(k) number K232020. The device is classified under product code EGJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Iontophoresis Electrodes?

Iontophoresis Electrodes is a medical device that received FDA 510(k) clearance on 2023-10-16. The listed applicant is Top-Rank Health Care Co., Ltd.. The 510(k) number is K232020.

When did Iontophoresis Electrodes receive FDA 510(k) clearance?

Iontophoresis Electrodes received FDA 510(k) clearance on 2023-10-16, under 510(k) number K232020.

Who is the listed applicant for Iontophoresis Electrodes?

The FDA 510(k) record lists Top-Rank Health Care Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Iontophoresis Electrodes?

The FDA product code for Iontophoresis Electrodes is EGJ.

Other records listing Top-Rank Health Care Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: EGJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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