The following data is part of a premarket notification filed by Xtreem Pulse, Llc with the FDA for Purelift.
Device ID | K190269 |
510k Number | K190269 |
Device Name: | PureLift |
Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
Applicant | Xtreem Pulse, LLC 353 W. 29 St., Suite 3 New York, NY 10001 |
Contact | Andrew Berile |
Correspondent | Rhonda Alexander IUVO Consulting, LLC PO Box 56436 Virginia Beach, VA 23456 |
Product Code | NFO |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-02-08 |
Decision Date | 2019-08-28 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860008851024 | K190269 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PURELIFT 87729700 5553705 Live/Registered |
Xtreem Pulse LLC 2017-12-21 |
PURELIFT 79241382 5864709 Live/Registered |
Hettich Marketing- und Vertriebs GmbH &Co. KG 2018-06-25 |
PURELIFT 76718057 not registered Dead/Abandoned |
GARDEN SPRINGS., LL.C. 2015-05-26 |
PURELIFT 76517991 2865588 Dead/Cancelled |
AUSTRALIAN GOLD, INC. 2003-05-29 |
PURELIFT 76221376 not registered Dead/Abandoned |
Mellon, Micheal G. 2001-03-07 |