Cleared Traditional

K080533 - WINCO MODEL POWER SERIES LIFT CHAIR

K080533 is an FDA 510(k) clearance for WINCO MODEL POWER SERIES LIFT CHAIR, manufactured by Winco, Inc.. The device is a Class 2 Physical Medicine device with product code INO cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K080533 · Winco, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
167d
Days
Class 2
Risk

K080533 is an FDA 510(k) clearance for the WINCO MODEL POWER SERIES LIFT CHAIR. Classified as Chair, Positioning, Electric (product code INO), Class II - Special Controls.

Submitted by Winco, Inc. (Ocala, US). The FDA issued a Cleared decision on August 11, 2008 after a review of 167 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3110 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K080533

510(k) Number K080533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2008
Decision Date August 11, 2008
Days to Decision 167 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 116d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INO Device Classification - Class 2, Special Controls

Product Code INO Chair, Positioning, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3110
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - INO Chair, Positioning, Electric

All 49
Devices cleared under the same product code (INO) and FDA review panel - the closest regulatory comparables to K080533.
MEDICAL TREATMENT CHAIR, T400, T500,T600
K091727 · Fresenius Medical Care South Asia Pacific Pty , Ltd. · Jul 2009
STANDARD WHEELCHAIR PLATFORM
K073565 · Design Specific , Ltd. · Feb 2009
PIVOT ASSIST
K081053 · Pivot Assist, LLC · Oct 2008
CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR
K071793 · Barton Medical Corp. · Aug 2007
LIFT CHAIR, MODEL C5
K070950 · Pride Mobility Products Corp. · Apr 2007
EASYSTAND EVOLV
K062402 · Invacare Corp. · Sep 2006
K080533 · WINCO MODEL POWER SERIES LIFT CHAIR
Download PDF FDA Summary Winco, Inc.