Cleared Traditional

K875034 - SWEDE CHAMP (WHEELCHAIR)

K875034 is the FDA 510(k) clearance for SWEDE CHAMP (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 36-day FDA review.

K875034 · Etac Us, Inc. · Physical Medicine device
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Jan 1988
Decision
36d
Days
Class 1
Risk

K875034 is an FDA 510(k) clearance for the SWEDE CHAMP (WHEELCHAIR). Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Etac Us, Inc. (Glendale, US). The FDA issued a Cleared decision on January 12, 1988 after a review of 36 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 K875034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1987
Decision Date January 12, 1988
Days to Decision 36 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 115d · This submission: 36d
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 K875034.
INVACARE YOUTHMOBILE 5000 SERIES WHEELCHAIR
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K881762 · Invacare Corp. · May 1988
2000LT WHEELCHAIR
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THE MOVER
K853424 · Invacare Corp. · Nov 1985
PLAIN JANE SERIES WHEELCHAIR
K842232 · Invacare Corp. · Jun 1984