K130631 is an FDA 510(k) clearance for the BUZZY. This device is classified as a Cold Pack And Vibrating Massager (Class I - General Controls, product code PHW).
Submitted by Mmj Labs, LLC (Atlanta, US). The FDA issued a Cleared decision on August 13, 2014, 523 days after receiving the submission on March 8, 2013.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5975. Relief Of Minor Aches And Pains, Controlling The Pain Associated With Needle Sticks (injections, Iv, Venipuncture)..
| 510(k) Number | K130631 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 2013 |
| Decision Date | August 13, 2014 |
| Days to Decision | 523 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | PHW - Cold Pack And Vibrating Massager |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5975 |
| Definition | Relief Of Minor Aches And Pains, Controlling The Pain Associated With Needle Sticks (injections, Iv, Venipuncture). |