FDA 510(k) Application Details - K203525

Device Classification Name	Stimulator, Muscle, Powered, Dental   More FDA Info for this Device
510(K) Number	K203525
Device Name	Stimulator, Muscle, Powered, Dental
Applicant	ITO CO., LTD. 3-1-8 Sakae-cho Kawaguchi-shi 332-0017 JP Other 510(k) Applications for this Company
Contact	Takeshi Kobayashi Other 510(k) Applications for this Contact
Regulation Number	890.5850   More FDA Info for this Regulation Number
Classification Product Code	NUW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/01/2020
Decision Date	05/05/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review