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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cold Pack And Vibrating Massager
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 Ave. Lw08
Atlanta,  GA  30307
Applicant Contact Amy Baxter
Correspondent
RQM+
195 Arizona Ave. Lw08
Atlanta,  GA  30307
Correspondent Contact Amy Baxter
Regulation Number890.5975
Classification Product Code
PHW  
Subsequent Product Code
IME  
Date Received09/30/2020
Decision Date 05/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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