Cleared Traditional

COMBI SELF PROPELLED SHOWER COMMODE (K040677) - FDA 510(k) Clearance

Class I Physical Medicine device.

K040677 · Kjaerulff Rehabilitation A/S · Physical Medicine device
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May 2004
Decision
66d
Days
Class 1
Risk

K040677 is an FDA 510(k) clearance for the COMBI SELF PROPELLED SHOWER COMMODE. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Kjaerulff Rehabilitation A/S (Otterup, DK). The FDA issued a Cleared decision on May 20, 2004 after a review of 66 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 Kjaerulff Rehabilitation A/S devices

Submission Details

510(k) Number K040677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2004
Decision Date May 20, 2004
Days to Decision 66 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
49d faster than avg
Panel avg: 115d · This submission: 66d
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 456
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K040677.
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