Cleared Traditional

K870297 - DAKOTA MODEL 102C WHEELCHAIR

K870297 is an FDA 510(k) clearance for DAKOTA MODEL 102C WHEELCHAIR, 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 13-day FDA review.

K870297 · Redman, Inc. · Physical Medicine device
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Feb 1987
Decision
13d
Days
Class 2
Risk

K870297 is an FDA 510(k) clearance for the DAKOTA MODEL 102C WHEELCHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special 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 890.3860 - 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.

FDA 510(k) Submission Details - K870297

510(k) Number K870297 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. 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 598
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K870297.
PERMOBIL MINIOR
K870226 · Permobil of America · Feb 1987
PERMOBIL SUPERIOR
K870227 · Permobil of America · Feb 1987
PERMOBIL HEXIOR
K870228 · Permobil of America · Feb 1987
A-BEC FIREBALL 40
K865001 · A-Bec Mobility, Inc. · Feb 1987
A-BEC 46
K865003 · A-Bec Mobility, Inc. · Feb 1987
A-BEC 40 POWER WHEELCHAIR
K865004 · A-Bec Mobility, Inc. · Feb 1987
K870297 · DAKOTA MODEL 102C WHEELCHAIR
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