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510(k) K130631

Device
BUZZY
Applicant
MMJ LABS, LLC
510(k) number
K130631
Product code
PHW  
Decision
Substantially Equivalent (SESE)
Decision date
2014-08-13
Date received
2013-03-08
Regulation
890.5975
Classification name
Cold Pack And Vibrating Massager
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
VALERIE STAFFEY
Address
322 Sutherland Pl. Atlanta GA US 30307 30307

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code PHW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K202993Buzzy® (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)Mmj Labs, LLC2023-05-15

Legacy Summary#

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FDA Review#

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