FDA 510(k) Application Details - K232439

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K232439
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Gymmax Technology Shenzen Co., Ltd. East 5F, A2 Building, Huimingsheng DingFeng Technology Park, Fuhai Street, Fuyong Town, Baoan District ShenZhen city 518103 CN Other 510(k) Applications for this Company
Contact	Benson Wang 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	08/14/2023
Decision Date	03/21/2024
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