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PureLift Pro Plus

by Xtreem Pulse, LLC

510(k) K221443

PureLift Pro Plus is a medical device (FDA Class II; FDA product code NFO, Stimulator, Transcutaneous Electrical, Aesthetic Purposes) made by Xtreem Pulse, LLC, cleared under FDA 510(k) K221443 on 21 Oct 2022, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK221443 Date21 Oct 2022ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
NFO
Device class
Class II
Regulation
21 CFR Part 882.5890
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K221443

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K221443
UDI-DISize and differences
PURELIFT PRO PLUS
Xtreem Pulse, LLC
PURELIFT PRO PLUS / PRO PLUS00860008851031
Height 20.7 cm; Width 4.8 cm; Outer Diameter 4.5 cm
On the market

Similar devices

Other devices filed under FDA product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes).

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