K221443 is an FDA 510(k) clearance for the PureLift Pro Plus. This device is classified as a Stimulator, Transcutaneous Electrical, Aesthetic Purposes (Class II - Special Controls, product code NFO).
Submitted by Xtreem Pulse, LLC (New York, US). The FDA issued a Cleared decision on October 21, 2022, 156 days after receiving the submission on May 18, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K221443 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2022 |
| Decision Date | October 21, 2022 |
| Days to Decision | 156 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | NFO - Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |