Cleared Abbreviated

K072311 - TILITE AERO X

K072311 is an FDA 510(k) clearance for TILITE AERO X, manufactured by Tisport, LLC. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Abbreviated 510(k) pathway after a 35-day FDA review.

K072311 · Tisport, LLC · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
35d
Days
Class 1
Risk

K072311 is an FDA 510(k) clearance for the TILITE AERO X. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Tisport, LLC (Kennewick, US). The FDA issued a Cleared decision on September 21, 2007 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - the FDA physical medicine device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K072311

510(k) Number K072311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2007
Decision Date September 21, 2007
Days to Decision 35 days
Submission Type Abbreviated
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
81d faster than avg
Panel avg: 116d · This submission: 35d
Pathway characteristics
Standards-based clearance path.

IOR Device Classification - Class 1, General Controls

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
Definition A Mechanical Wheelchair Is A Manually Operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets “mobility To Persons Restricted To A Sitting Position” To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And/or Require An Assistive Device For Mobility.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IOR Wheelchair, Mechanical

All 441
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K072311.
DANYANG HUAYI K2 AND K7 WHEELCHAIRS
K080207 · Danyang Huayi Medical Supply & Equipment Co, Ltd. · Mar 2008
HUAYI H035 BASIC WHEELCHAIR
K080114 · Danyang Huayi Medical Supply & Equipment Co, Ltd. · Feb 2008
START JUNIOR
K073512 · Otto Bock Healthcare LP · Jan 2008
QUICKIE QX MANUAL FOLDING WHEELCHAIR
K072153 · Sunrise Medical, Inc. · Sep 2007
MECHANICAL WHEELCHAIR - L-FRAME SERIES
K071444 · Colours 'N Motion · Jul 2007
MAXHEALTH MECHANICAL WHEELCHAIR, K1
K070176 · Maxhealth Corp. · Mar 2007
K072311 · TILITE AERO X
Download PDF FDA Summary Tisport, LLC