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510(k) Data Aggregation
K Number
K242041Device Name
STOPWET iontophoresis apparatus (SW01)
Manufacturer
Taiwan Medical Electronics Co., Ltd.
Date Cleared
2025-04-01
(263 days)
Product Code
EGJ
Regulation Number
890.5525Why did this record match?
Applicant Name (Manufacturer) :
Taiwan Medical Electronics Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
STOPWET is a Tap Water Iontophoresis apparatus. Its intended use is to treat hyperhidrosis (excessive sweating) of the hands and feet.
Device Description
STOPWET is designed for individuals suffering from hyperhidrosis (excessive sweating) of the hands and feet. It includes a pulse current generator and two pairs of containers for performing iontophoresis therapy specifically for hyperhidrosis. Users are required to place their hands or feet inside the containers, which contain dampened absorbent pads, and adjust the amplitude of the pulse current to a comfortable level. The circuit for the pulse current is limited to the distal end of the user's hands or feet, thereby minimizing the risk of cardiac discomfort. Additionally, users have the option to treat either the left or right hand using the single-limb treatment mode or treat both hands simultaneously with the dual-limb treatment mode. STOPWET can be used either in a clinical setting or at home. STOPWET is intended for users aged 13 years and above, including teenagers and adults. For teenagers aged 13 to 21 years, it is recommended to use this apparatus under adult supervision.
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