510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K221443Substantially Equivalent

PureLift Pro Plus

Xtreem Pulse, New York NY / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221443 is the FDA 510(k) clearance record for PureLift Pro Plus, a class II device, cleared for Xtreem Pulse, LLC on under FDA product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes). FDA records list 5 510(k) clearances for Xtreem Pulse, LLC, from to . As of , FDA records show no recalls naming K221443.

Clearance record

Decision date
Received
(156 days to decision)
Product code
NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Xtreem Pulse, LLC 353 W. 29 St. Suite 3, New York NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NFO

Trailing 12 months
9 clearances under product code NFO in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code NFO, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20260
April 20260
May 20262
June 20261
July 20261
August 20261
September 20262
October 20260