510(k) K130631
K130631 is an FDA 510(k) premarket notification submitted by Mmj Labs, LLC for the device "BUZZY". The FDA issued a decision of Substantially Equivalent on August 13, 2014. 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
- August 13, 2014
- Date Received
- March 8, 2013
- 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).