FDA 510(k) Application Details - K200838

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K200838
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Tyece Limited Unit 803, Block A, Po Lung Centre, 11 Wang Chiu Rd, Kowloon Bay Kowloon CN Other 510(k) Applications for this Company
Contact	Parshid Falahati Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	NUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/2020
Decision Date	08/12/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review