RENEGADE WHEELCHAIR— 510(k) K082857

Substantially Equivalent

Alpha One

FDA 510(k) clearance K082857 for RENEGADE WHEELCHAIR, Substantially Equivalent on 2009-01-06. Applicant: Alpha One. Device class: 2.

Clearance details

Applicant: Alpha One
Product code: Code IQC
Device class: Class 2
Regulation: 21 CFR 890.3880
Advisory panel: Physical Medicine
Date received: 2008-09-29
Decision date: 2009-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chevy Chase, MD, 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.