Cleared Traditional

K920325 - RANGEROLLER (MODIFIED)

K920325 is an FDA 510(k) clearance for RANGEROLLER (MODIFIED), manufactured by Excel Mobility Products, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K920325 · Excel Mobility Products, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
51d
Days
Class 2
Risk

K920325 is an FDA 510(k) clearance for the RANGEROLLER (MODIFIED). Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Excel Mobility Products, Inc. (Washington, US). The FDA issued a Cleared decision on March 6, 1992 after a review of 51 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 Excel Mobility Products, Inc. devices

FDA 510(k) Submission Details - K920325

510(k) Number K920325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1992
Decision Date March 06, 1992
Days to Decision 51 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 115d · This submission: 51d
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 405
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K920325.
ACTION TIGER POWERED WHEELCHAIR
K930676 · Invacare Corp. · Mar 1994
TILT/REDUCED SHEAR SEMI-RECLINE SEATING SYSTEM
K923365 · Labsystems, Inc. · Mar 1993
FORTRESS 760-N 4 WHEEL POWER WHEELCHAIR
K921070 · Fortress Scientific , Ltd. · May 1992
MICRO COMPUTER CONTROLS, MODEL# MCC-MK-RII-X
K914938 · Invacare Corp. · Jan 1992
SPECIALTY CONTROLS INTERFACE
K913645 · Everest & Jennings, Inc. · Dec 1991
POWER RECLINER WHEELCHAIR
K914091 · Everest & Jennings, Inc. · Nov 1991