FDA 510(k) Application Details - K202993

Device Classification Name	More FDA Info for this Device
510(K) Number	K202993
Device Name	Buzzy« (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool« (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H)
Applicant	MMJ Labs, LLC 195 Arizona Avenue, LW08 Atlanta, GA 30307 US Other 510(k) Applications for this Company
Contact	Amy Baxter Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2020
Decision Date	05/15/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review