medi pneumatic compression system (pcs)-genius (Model 652)— 510(k) K221654

Name: FDA 510(k) clearance K221654
Creator: U.S. Food and Drug Administration
Published: 2022-07-07

Substantially Equivalent

Medi USA, LP

FDA 510(k) clearance K221654 for medi pneumatic compression system (pcs)-genius (Model 652), Substantially Equivalent on 2022-07-07. Applicant: Medi USA, LP. Device class: 2.

Clearance details

Applicant: Medi USA, LP
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2022-06-07
Decision date: 2022-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Whitsett, NC, 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.