Cleared Traditional

K073565 - STANDARD WHEELCHAIR PLATFORM

K073565 is an FDA 510(k) clearance for STANDARD WHEELCHAIR PLATFORM, manufactured by Design Specific , Ltd.. The device is a Class 2 Physical Medicine device with product code INO cleared through the Traditional 510(k) pathway after a 415-day FDA review.

K073565 · Design Specific , Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
415d
Days
Class 2
Risk

K073565 is an FDA 510(k) clearance for the STANDARD WHEELCHAIR PLATFORM. Classified as Chair, Positioning, Electric (product code INO), Class II - Special Controls.

Submitted by Design Specific , Ltd. (Norfolk, US). The FDA issued a Cleared decision on February 6, 2009 after a review of 415 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

FDA 510(k) Submission Details - K073565

510(k) Number K073565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2007
Decision Date February 06, 2009
Days to Decision 415 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
299d slower than avg
Panel avg: 116d · This submission: 415d
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 K073565.
LIFT CHAIR, MODEL T3
K091578 · Pride Mobility Products Corp. · Dec 2009
BANTAM
K091242 · Altimate Medical, Inc. · Jul 2009
MEDICAL TREATMENT CHAIR, T400, T500,T600
K091727 · Fresenius Medical Care South Asia Pacific Pty , Ltd. · Jul 2009
PIVOT ASSIST
K081053 · Pivot Assist, LLC · Oct 2008
WINCO MODEL POWER SERIES LIFT CHAIR
K080533 · Winco, Inc. · Aug 2008
CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR
K071793 · Barton Medical Corp. · Aug 2007
K073565 · STANDARD WHEELCHAIR PLATFORM
Download PDF FDA Summary Design Specific , Ltd.