Cleared Abbreviated

K982750 - CORSAIRE

K982750 is an FDA 510(k) clearance for CORSAIRE, manufactured by Optiway, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Abbreviated 510(k) pathway after a 179-day FDA review.

K982750 · Optiway, Inc. · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Feb 1999
Decision
179d
Days
Class 2
Risk

K982750 is an FDA 510(k) clearance for the CORSAIRE. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Optiway, Inc. (Washington, US). The FDA issued a Cleared decision on February 1, 1999 after a review of 179 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - 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.

View all Optiway, Inc. devices

FDA 510(k) Submission Details - K982750

510(k) Number K982750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1998
Decision Date February 01, 1999
Days to Decision 179 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 115d · This submission: 179d
Pathway characteristics
Standards-based clearance path.

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 294
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K982750.
TILT/RECLINER FOR POWER WHEELCHAIRS, MODEL 2G
K991119 · Invacare Corp. · Aug 1999
THERADYNE ROVER POWERED WHEELCHAIR
K982724 · Kurt Mfg. Co. · Aug 1999
ARROW FWD POWER WHEELCHAIR
K991168 · Invacare Corp. · Jun 1999
FIRSTCLASS POWER TILT SEAT SYSTEM, MODEL S300
K983066 · Teftec Corp. · Nov 1998
QUICKIE P100 SERIES, QUICKIE P200 SERIES, QUICKIE P300 SERIES, MODELS P100,P110,P120,P190,P190R,P500,P200,P210,P320,P300
K981462 · Sunrise Medical, Inc. · Nov 1998
ALPHATRAC, MODEL A200
K982815 · Teftec Corp. · Nov 1998