510(k) K202993
K202993 is an FDA 510(k) premarket notification submitted by Mmj Labs, LLC for the device "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)". The FDA issued a decision of Substantially Equivalent on May 15, 2023. The device falls under product code PHW (Cold Pack And Vibrating Massager), a Class I device regulated under 21 CFR 890.5975. Mmj Labs, LLC has at least 1 other 510(k) clearance on record.
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).