FDA 510(k) Application Details - K233046

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K233046
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	Oriental Inspiration Limited Unit D (01), 14/F.,Block 1,Tai Ping Industrial Centre,No. 57 Ting Kok Road, Tai Po,New Territories Hong Kong CN Other 510(k) Applications for this Company
Contact	Francis Ko Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	GZJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2023
Decision Date	04/19/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review