Cleared Traditional

K010364 - MCC-MIV ONE 2 ONE SOFTWARE

K010364 is an FDA 510(k) clearance for MCC-MIV ONE 2 ONE SOFTWARE, manufactured by Invacare Corp.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K010364 · Invacare Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
43d
Days
Class 2
Risk

K010364 is an FDA 510(k) clearance for the MCC-MIV ONE 2 ONE SOFTWARE. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on March 22, 2001 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Invacare Corp. devices

FDA 510(k) Submission Details - K010364

510(k) Number K010364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2001
Decision Date March 22, 2001
Days to Decision 43 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
73d faster than avg
Panel avg: 116d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITI Device Classification - Class 2, Special Controls

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-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 Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
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 - ITI Wheelchair, Powered

All 452
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K010364.
MP3HD BIG BOY, POWER WHEELCHAIR
K010380 · Merits Health Products., Inc. · May 2001
OPTIMA
K011053 · Medical Industries America, Inc. · Apr 2001
THE LIBERATOR WHEELCHAIR
K010859 · Liberator Wheelchairs, Inc. · Apr 2001
E MOTION WHEELCHAIR DRIVE SYSTEM (POWER-ASSIST FOR MANUAL WHEELCHAIRS)
K003449 · Ulrich Alber GmbH & Co. · Mar 2001
TEKNIQUE
K010075 · Hoveround Corp. · Feb 2001
TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM
K010011 · Accelerated Rehab Designs, Inc. · Jan 2001