Cleared Abbreviated

K982724 - THERADYNE ROVER POWERED WHEELCHAIR

K982724 is an FDA 510(k) clearance for THERADYNE ROVER POWERED WHEELCHAIR, manufactured by Kurt Mfg. Co.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Abbreviated 510(k) pathway after a 372-day FDA review.

K982724 · Kurt Mfg. Co. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
372d
Days
Class 2
Risk

K982724 is an FDA 510(k) clearance for the THERADYNE ROVER POWERED WHEELCHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Kurt Mfg. Co. (Minneapolis, US). The FDA issued a Cleared decision on August 12, 1999 after a review of 372 days - an unusually long review period, suggesting complex equivalence evaluation.

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

FDA 510(k) Submission Details - K982724

510(k) Number K982724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1998
Decision Date August 12, 1999
Days to Decision 372 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
257d slower than avg
Panel avg: 115d · This submission: 372d
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 K982724.
MODEL CGS TILT SEATING SYSTEM FOR POWER WHEELCHAIRS
K001777 · Invacare Corp. · Jul 2000
STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROL
K993413 · Invacare Corp. · Dec 1999
TILT/RECLINER FOR POWER WHEELCHAIRS, MODEL 2G
K991119 · Invacare Corp. · Aug 1999
ARROW FWD POWER WHEELCHAIR
K991168 · Invacare Corp. · Jun 1999
CORSAIRE
K982750 · Optiway, Inc. · Feb 1999
FIRSTCLASS POWER TILT SEAT SYSTEM, MODEL S300
K983066 · Teftec Corp. · Nov 1998