Atlas FDA

PHW

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Cold Pack And Vibrating Massager
Device class
Class I (low risk)
Regulation
21 CFR 890.5975
Medical specialty
Physical Medicine
FDA definition
Relief of minor aches and pains, controlling the pain associated with needle sticks (injections, IV, venipuncture).
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RecordFirmDateBuilder
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) (K202993)Mmj Labs, LLC2023-05-15+ Add
BUZZY (K130631)Mmj Labs, LLC2014-08-13+ Add

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