PureLift Pro Plus— 510(k) K221443

Substantially Equivalent

Xtreem Pulse, LLC

FDA 510(k) clearance K221443 for PureLift Pro Plus, Substantially Equivalent on 2022-10-21. Applicant: Xtreem Pulse, LLC. Device class: 2.

Clearance details

Applicant: Xtreem Pulse, LLC
Product code: Code NFO
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2022-05-18
Decision date: 2022-10-21
Decision: Substantially Equivalent
Clearance type: Special
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NFO

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K260387 — SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)2026-08-31
K253932 — FACEGYM Pro Device (HD-109)2026-07-23
K260179 — VITA Multi-Function Head Brush (TB-2343F, TB-2442F)2026-06-03
K260895 — Ulike Clear Zero (YC10 BU)2026-05-28

More clearances from Xtreem Pulse, LLC

K243587 — PureLift GLOW2025-03-06
K190269 — PureLift2019-08-28
K173483 — Pure Flow External Counter-Pulsation Device2018-05-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.