FDA 510(k) Application Details - K242186

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K242186
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	OFAN Intelligent Technology (Guangzhou) Co. Ltd. Floor 4rd Building F, Jintai Creation Park Jiahuo Helong No. 1 Rd. NO 6, Baiyun District Guangzhou 510000 CN Other 510(k) Applications for this Company
Contact	Tequila Chan 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	07/25/2024
Decision Date	09/17/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review