K202993 is an FDA 510(k) clearance for the Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro). 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 May 15, 2023, 957 days after receiving the submission on September 30, 2020.
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 | K202993 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2020 |
| Decision Date | May 15, 2023 |
| Days to Decision | 957 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| 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). |