EMS (FlexPulse, MagnaCore, Magnetika)— 510(k) K241601

Name: FDA 510(k) clearance K241601
Creator: U.S. Food and Drug Administration
Published: 2025-02-25

Substantially Equivalent

Cpmt Laser (Canadian Pioneer Medical Technology Corporation)

FDA 510(k) clearance K241601 for EMS (FlexPulse, MagnaCore, Magnetika), Substantially Equivalent on 2025-02-25. Applicant: Cpmt Laser (Canadian Pioneer Medical Technology Corporation). Device class: 2.

Clearance details

Applicant: Cpmt Laser (Canadian Pioneer Medical Technology Corporation)
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2024-06-04
Decision date: 2025-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

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