The following data is part of a premarket notification filed by Xtreem Pulse Llc with the FDA for Purelift Pro Plus.
| Device ID | K221443 |
| 510k Number | K221443 |
| Device Name: | PureLift Pro Plus |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | Xtreem Pulse LLC 353 W. 29 St. Suite 3 New York, NY 10001 |
| Contact | Andrew Barile |
| Correspondent | Andrew Barile Xtreem Pulse LLC 353 W. 29 St. Suite 3 New York, NY 10001 |
| Product Code | NFO |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-18 |
| Decision Date | 2022-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860008851031 | K221443 | 000 |