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510(k) K242041

STOPWET iontophoresis apparatus (SW01) by Taiwan Medical Electronics Co., Ltd. — Product Code EGJ

K242041 is an FDA 510(k) premarket notification submitted by Taiwan Medical Electronics Co., Ltd. for the device "STOPWET iontophoresis apparatus (SW01)". The FDA issued a decision of Substantially Equivalent on April 1, 2025. The device falls under product code EGJ (Device, Iontophoresis, Other Uses), a Class II device regulated under 21 CFR 890.5525.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2025
Date Received
July 12, 2024
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 for product code EGJ

  • K241267 — Hidroxa SE30 (October 17, 2024)
  • K232020 — Iontophoresis Electrodes (October 16, 2023)
  • 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)

FDA data resources