WMI REPROCESSED DVT WRAP, WMI REPROCESSED THERMAL WRAP MODEL: RD-1000F, RD-1000C, RT 2000A, RT 2000B, RT 2000KF, RT 2000— 510(k) K101035

Name: FDA 510(k) clearance K101035
Creator: U.S. Food and Drug Administration
Published: 2010-10-29

Substantially Equivalent

Wmi Enterprises, LLC

FDA 510(k) clearance K101035 for WMI REPROCESSED DVT WRAP, WMI REPROCESSED THERMAL WRAP MODEL: RD-1000F, RD-1000C, RT 2000A, RT 2000B, RT 2000KF, RT 2000, Substantially Equivalent on 2010-10-29. Applicant: Wmi Enterprises, LLC. Device class: 2.

Clearance details

Applicant: Wmi Enterprises, LLC
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2010-04-14
Decision date: 2010-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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