PlasmaFlow X Compression Sleeve Device (XPF0001)— 510(k) K251446

Name: FDA 510(k) clearance K251446
Creator: U.S. Food and Drug Administration
Published: 2025-09-17

Substantially Equivalent

Manamed, LLC

FDA 510(k) clearance K251446 for PlasmaFlow X Compression Sleeve Device (XPF0001), Substantially Equivalent on 2025-09-17. Applicant: Manamed, LLC. Device class: 2.

Clearance details

Applicant: Manamed, LLC
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2025-05-09
Decision date: 2025-09-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Denton, TX, US

Download summary PDF View on FDA.gov ↗

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