FDA 510(k) Application Details - K213091

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K213091
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Well-Life Healthcare Limited 6F., No.168, Lide St., Jhonghe District New Taipei City 235 TW Other 510(k) Applications for this Company
Contact	Jenny Hsieh 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	09/24/2021
Decision Date	02/19/2022
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