Cleared Traditional

EASYSTAND EVOLV

K062402 · Invacare Corp. · Physical Medicine
Sep 2006
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K062402 is an FDA 510(k) clearance for the EASYSTAND EVOLV, a Chair, Positioning, Electric (Class II — Special Controls, product code INO), submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on September 21, 2006, 35 days after receiving the submission on August 17, 2006. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3110.

Submission Details

510(k) Number K062402 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 2006
Decision Date September 21, 2006
Days to Decision 35 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code INO — Chair, Positioning, Electric
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.3110

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