Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

STOPWET iontophoresis apparatus (SW01)

K-Number: K242041 · 2025-04-01

Decision Date2025-04-01
Product CodeEGJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

STOPWET iontophoresis apparatus (SW01) is a medical device manufactured by Taiwan Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-04-01 under approval number K242041. 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 STOPWET iontophoresis apparatus (SW01)?

STOPWET iontophoresis apparatus (SW01) is a medical device that received FDA 510(k) clearance on 2025-04-01. It is manufactured by Taiwan Medical Electronics Co., Ltd.. The 510(k) number is K242041.

When was STOPWET iontophoresis apparatus (SW01) approved by the FDA?

STOPWET iontophoresis apparatus (SW01) received FDA 510(k) clearance on 2025-04-01, under approval number K242041.

What company makes STOPWET iontophoresis apparatus (SW01)?

STOPWET iontophoresis apparatus (SW01) is manufactured by Taiwan Medical Electronics Co., Ltd..

What is the FDA product code for STOPWET iontophoresis apparatus (SW01)?

The FDA product code for STOPWET iontophoresis apparatus (SW01) is EGJ.

Related Devices (Code: EGJ)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.