FDA 510(k) Application Details - K183454

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K183454
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	Tyece Ltd. Unit 801, Block A, Po Lung Centre, 11 Wang Chiu Rd. Kowloon Bay Kowloon, Hong Kong HK Other 510(k) Applications for this Company
Contact	Parshid Falahati 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	12/13/2018
Decision Date	02/26/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review