Cleared Traditional

K870291 - CHEROKEE MODEL 102A WHEELCHAIR

K870291 is an FDA 510(k) clearance for CHEROKEE MODEL 102A WHEELCHAIR, manufactured by Redman, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K870291 · Redman, Inc. · Physical Medicine device
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Feb 1987
Decision
13d
Days
Class 1
Risk

K870291 is an FDA 510(k) clearance for the CHEROKEE MODEL 102A WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Redman, Inc. (Bloomington, US). The FDA issued a Cleared decision on February 10, 1987 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - 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.

FDA 510(k) Submission Details - K870291

510(k) Number K870291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1987
Decision Date February 10, 1987
Days to Decision 13 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
103d faster than avg
Panel avg: 116d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

IOR Device Classification - Class 1, General Controls

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
Definition A Mechanical Wheelchair Is A Manually 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/or Require An Assistive Device For Mobility.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IOR Wheelchair, Mechanical

All 466
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K870291.
FOLDING WHEELCHAIR
K872940 · Health Care Innovations, Inc. · Aug 1987
AUTO ENTRY SYSTEM (MATE)
K870425 · Kg Engineering, Inc. · Mar 1987
QUICKIE RX PRESCRIPTION WHEELCHAIR
K870476 · Motion Designs, Inc. · Feb 1987
CHEYENNE MODEL 107A WHEELCHAIR
K870292 · Redman, Inc. · Feb 1987
NAVAJO MODEL 103A WHEELCHAIR
K870293 · Redman, Inc. · Feb 1987
CROW MODEL 106A WHEELCHAIR
K870294 · Redman, Inc. · Feb 1987
K870291 · CHEROKEE MODEL 102A WHEELCHAIR
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