FDA 510(k) Application Details - K242041

Device Classification Name	Device, Iontophoresis, Other Uses   More FDA Info for this Device
510(K) Number	K242041
Device Name	Device, Iontophoresis, Other Uses
Applicant	Taiwan Medical Electronics Co., Ltd. Rm. 5, 3F., No. 49, Sec. 3, Zhongshan N. Rd., Zhongshan Dist. Taipei City 104029 TW Other 510(k) Applications for this Company
Contact	Chi-Lin Chen Other 510(k) Applications for this Contact
Regulation Number	890.5525   More FDA Info for this Regulation Number
Classification Product Code	EGJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/12/2024
Decision Date	04/01/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review