510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K202993Substantially Equivalent

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)

Mmj Labs, LLC, Atlanta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K202993 is the FDA 510(k) clearance record for 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), a class I device, cleared for Mmj Labs, LLC on under FDA product code PHW (Cold Pack And Vibrating Massager). FDA's definition for product code PHW reads: "Relief of minor aches and pains, controlling the pain associated with needle sticks (injections, IV, venipuncture)". FDA records list 2 510(k) clearances for Mmj Labs, LLC, from to . As of , FDA records show no recalls naming K202993.

Clearance record

Decision date
Received
(957 days to decision)
Product code
PHW Cold Pack And Vibrating Massager
Regulation
21 CFR 890.5975
Device class
Class I
Review panel
Physical Medicine
Applicant
Mmj Labs, LLC 195 Arizona Ave. Lw08, Atlanta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PHW

Trailing 12 months

FDA records hold no clearances under product code PHW in the trailing twelve months.

FDA records show no clearances under product code PHW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PHW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260