Cleared Traditional

K914610 - SWEDE CROSS MANUAL WHEELCHAIR

K914610 is the FDA 510(k) clearance for SWEDE CROSS MANUAL WHEELCHAIR by Etac Us, Inc.. It is a Class 1 Physical Medicine device (product code IOR) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K914610 · Etac Us, Inc. · Physical Medicine device
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Nov 1991
Decision
43d
Days
Class 1
Risk

K914610 is an FDA 510(k) clearance for the SWEDE CROSS MANUAL WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Etac Us, Inc. (Waukesha, US). The FDA issued a Cleared decision on November 29, 1991 after a review of 43 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.

View all Etac Us, Inc. devices

Submission Details

510(k) Number K914610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1991
Decision Date November 29, 1991
Days to Decision 43 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 115d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 78
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K914610.
ACTION WIZARD PEDIATRIC MANUAL WHEELCHAIR
K934646 · Invacare Corp. · Dec 1993
ACTION FX MANUAL WHEELCHAIR
K921847 · Invacare Corp. · May 1992
VOYAGEUR AND LAURENTIAN SERIES WHEELCHAIR
K920391 · Invacare Corp. · Feb 1992
ACTION SERIES MANUAL WHEELCHAIRS, VARIOUS MODELS
K914553 · Invacare Corp. · Oct 1991
WORLD CHAIR
K894136 · Invacare Corp. · Jul 1989
ROLLS 3000 SERIES WHEELCHAIR (YOUTHMOBILE)
K884931 · Invacare Corp. · Dec 1988