FDA 510(k) Application Details - K250038

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K250038
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	Zhengzhou PZ Laser Slim Technology Co., Ltd. Room 201, 2nd Floor, Building 2, No. 52 Hongsong Road, High-tech Development Zone Zhengzhou 450001 CN Other 510(k) Applications for this Company
Contact	Hongwei Zhou Other 510(k) Applications for this Contact
Regulation Number	890.5850   More FDA Info for this Regulation Number
Classification Product Code	NGX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/08/2025
Decision Date	05/19/2025
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