Cleared Traditional

K940920 - ROAD SAVAGE

K940920 is an FDA 510(k) clearance for ROAD SAVAGE, manufactured by Redman, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 343-day FDA review.

K940920 · Redman, Inc. · Physical Medicine device
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Feb 1995
Decision
343d
Days
Class 2
Risk

K940920 is an FDA 510(k) clearance for the ROAD SAVAGE. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Redman, Inc. (Tucson, US). The FDA issued a Cleared decision on February 3, 1995 after a review of 343 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Redman, Inc. devices

FDA 510(k) Submission Details - K940920

510(k) Number K940920 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 25, 1994
Decision Date February 03, 1995
Days to Decision 343 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
228d slower than avg
Panel avg: 115d · This submission: 343d
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 401
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K940920.
GERONIMO
K935750 · Redman, Inc. · Feb 1995
GERONIMO PR
K935751 · Redman, Inc. · Feb 1995
RED PACK MANLUAL POWER WHEELCHAIR CONVERSION KIT
K940851 · Redman, Inc. · Feb 1995
ROAD WARRIOR
K935749 · Redman, Inc. · Jan 1995
POWER RECLINER
K944423 · Sunrise Medical, Inc. · Nov 1994
MODEL MCC - MKIV MICRO COMPUTER CONTROLS
K940972 · Invacare Corp. · Jun 1994