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PureLift Pro Edition

FDA 510(k)

Class II (US FDA 510(k))

510(k) K230506

by Xtreem Pulse

Identifiers

510(k) Number
K230506 FDA 510(k)
FDA Product Code
NFO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5890 FDA 510(k)
Regulation Number
882.5890 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

PureLift Pro Edition by Xtreem Pulse — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Xtreem Pulse

Sources (1)

  • FDA 510(k) K230506 24 fields · synced Jun 18, 2026