Cleared Traditional

K935750 - GERONIMO

K935750 is an FDA 510(k) clearance for GERONIMO, 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 434-day FDA review.

K935750 · Redman, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
434d
Days
Class 2
Risk

K935750 is an FDA 510(k) clearance for the GERONIMO. 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 434 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Redman, Inc. devices

FDA 510(k) Submission Details - K935750

510(k) Number K935750 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 26, 1993
Decision Date February 03, 1995
Days to Decision 434 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
319d slower than avg
Panel avg: 115d · This submission: 434d
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 K935750.
ORTHOFAB WHEELCHAIR
K952675 · Orthofab, Inc. · May 1996
POWERCHAIR
K954135 · Wheelcare Scooters, Inc. · Apr 1996
MODEL INT/DL40I MICRO COMPUTER CONTROLLER FOR POWER WHEELCHAIRS
K950724 · Invacare Corp. · Aug 1995
GERONIMO PR
K935751 · Redman, Inc. · Feb 1995
RED PACK MANLUAL POWER WHEELCHAIR CONVERSION KIT
K940851 · Redman, Inc. · Feb 1995
ROAD SAVAGE
K940920 · Redman, Inc. · Feb 1995