Home / 510(k) Clearances / K232020

510(k) K232020

Iontophoresis Electrodes by Top-Rank Health Care Co., Ltd. — Product Code EGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2023
Date Received
July 7, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Iontophoresis, Other Uses
Device Class
Class II
Regulation Number
890.5525
Review Panel
PM
Submission Type

Other clearances by Top-Rank Health Care Co., Ltd.

  • K222770 — Conductive Gel (December 13, 2022)
  • K210223 — Transcutaneous Electrical Nerve Stimulator (December 15, 2021)
  • K160366 — Electrosurgical disposable grounding pads (August 19, 2016)

Other clearances for product code EGJ

  • K242041 — STOPWET iontophoresis apparatus (SW01) (April 1, 2025)
  • K241267 — Hidroxa SE30 (October 17, 2024)
  • K192749 — Dermadry (February 10, 2020)
  • K191436 — Saalio (October 18, 2019)
  • K170835 — Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant (June 15, 2018)
  • K170291 — IontoDC (May 1, 2017)
  • K150453 — TULA Iontophoresis System with Earset (May 20, 2015)
  • K133033 — HIDREX PSP1000 (April 8, 2015)
  • K132832 — ACTIVAPATCH ET IONTOPHORESIS PATCH (February 13, 2014)
  • K110636 — TULA IONTOPHORESIS SYSTEM (June 16, 2011)