Cleared Traditional

MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION (K945667) - FDA 510(k) Clearance

Class I Physical Medicine device.

K945667 · Micos Medical Systems · Physical Medicine device
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Feb 1995
Decision
96d
Days
Class 1
Risk

K945667 is an FDA 510(k) clearance for the MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION. Classified as Cushion, Flotation (product code KIC), Class I - General Controls.

Submitted by Micos Medical Systems (Hickory Corners, US). The FDA issued a Cleared decision on February 21, 1995 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3175 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Micos Medical Systems devices

Submission Details

510(k) Number K945667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1994
Decision Date February 21, 1995
Days to Decision 96 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
19d faster than avg
Panel avg: 115d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIC Cushion, Flotation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3175
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.