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510(k) K202993

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) by Mmj Labs, LLC — Product Code PHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2023
Date Received
September 30, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cold Pack And Vibrating Massager
Device Class
Class I
Regulation Number
890.5975
Review Panel
PM
Submission Type

Relief of minor aches and pains, controlling the pain associated with needle sticks (injections, IV, venipuncture).

Other clearances by Mmj Labs, LLC

  • K130631 — BUZZY (August 13, 2014)

Other clearances for product code PHW

  • K130631 — BUZZY (August 13, 2014)