Device Classification Name |
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
|
510(k) Number |
K190269 |
Device Name |
PureLift |
Applicant |
Xtreem Pulse, LLC |
353 W. 29 St., Suite 3 |
New York,
NY
10001
|
|
Applicant Contact |
Andrew Berile |
Correspondent |
IUVO Consulting, LLC |
PO Box 56436 |
Virginia Beach,
VA
23456
|
|
Correspondent Contact |
Rhonda Alexander |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 02/08/2019 |
Decision Date | 08/28/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|