Cleared Traditional

K934297 - DURABLE MEDICAL EQUIPMENT COMPANY, STANDARD MECHANICAL WHEELCHAIR

K934297 is an FDA 510(k) clearance for DURABLE MEDICAL EQUIPMENT COMPANY, manufactured by Durable Medical Equipment, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K934297 · Durable Medical Equipment, Inc. · Physical Medicine device
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Nov 1993
Decision
60d
Days
Class 1
Risk

K934297 is an FDA 510(k) clearance for the DURABLE MEDICAL EQUIPMENT COMPANY, STANDARD MECHANICAL WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Durable Medical Equipment, Inc. (Pittsboro, US). The FDA issued a Cleared decision on November 1, 1993 after a review of 60 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 - K934297

510(k) Number K934297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1993
Decision Date November 01, 1993
Days to Decision 60 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 116d · This submission: 60d
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 K934297.
WIZARD PEDIATRIC WHEELCHAIR
K934560 · Snug Seat, Inc. · Jan 1994
ACTION WIZARD PEDIATRIC MANUAL WHEELCHAIR
K934646 · Invacare Corp. · Dec 1993
PORTABLE STANDARD
K934263 · Cloverleaf Cycle Co. · Nov 1993
TRAVEL EASE
K933406 · Merits Health Products., Inc. · Sep 1993
MICROLITE WHEELCHAIR
K933919 · Morgan Technology, Inc. · Sep 1993
ZERO GRAVITY WHEELCHAIR
K931751 · General Components Intl., Inc. · Jul 1993
K934297 · DURABLE MEDICAL EQUIPMENT COMPANY, STANDARD MECHANICAL WHEELCHAIR
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