Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro) +1 more— 510(k) K202993

Substantially Equivalent

Mmj Labs, LLC

FDA 510(k) clearance K202993 for Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro) +1 more, Substantially Equivalent on 2023-05-15. Applicant: Mmj Labs, LLC. Device class: 1.

Clearance details

Device name as filed
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
Product code
Code PHW
Device class
Class 1
Regulation
21 CFR 890.5975
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Atlanta, GA, US
Download summary PDFView on FDA.gov ↗

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