Clearance Summary
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) received FDA 510(k) clearance under submission number K202993, sponsored by Mmj Labs, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2023-05-15.
- Submission: K202993
- Applicant / Sponsor: Mmj Labs, LLC
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5975
- Decision date: 2023-05-15
Classification & Regulation
This clearance is catalogued under FDA product code PHW and 21 CFR 890.5975, within the Physical Medicine review panel as a Class I device.