Cleared Traditional

K110671 - WINCO STRETCHAIR (FDA 510(k) Clearance)

Apr 2011
Decision
44d
Days
Class 2
Risk

K110671 is an FDA 510(k) clearance for the WINCO STRETCHAIR. This device is classified as a Stretcher, Wheeled, Powered (Class II - Special Controls, product code INK).

Submitted by Winco Mfg., LLC (Ocala, US). The FDA issued a Cleared decision on April 22, 2011, 44 days after receiving the submission on March 9, 2011.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3690.

Submission Details

510(k) Number K110671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2011
Decision Date April 22, 2011
Days to Decision 44 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code INK — Stretcher, Wheeled, Powered
Device Class Class II - Special Controls
CFR Regulation 21 CFR 890.3690

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