# K242041: STOPWET iontophoresis apparatus (SW01)

- Pathway: 510(k) (Traditional)
- Applicant: Taiwan Medical Electronics Co., Ltd.
- Decided: Apr 1, 2025 after 263 days
- Product code: EGJ (Device, Iontophoresis, Other Uses)
- Device class: 2
- Regulation: 21 CFR 890.5525
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K831320 (1983). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192749: Dermadry, Dermadry Laboratories, Inc. (2020) Summary page 5.

## Indications for use
STOPWET is a Tap Water lontophoresis apparatus. Its intended use is to treat hyperhidrosis (excessive sweating) of the hands and feet. Using this apparatus in any other way than its intended purpose may be dangerous.

Source page: https://510kreport.com/device/K242041
Methodology: https://510kreport.com/methodology