Cleared Traditional

K864108 - PUSH CUSH (FDA 510(k) Clearance)

Class I Physical Medicine device.

K864108 · Medical Industries America, Inc. · Physical Medicine device
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Nov 1986
Decision
24d
Days
Class 1
Risk

K864108 is an FDA 510(k) clearance for the PUSH CUSH. Classified as Cushion, Flotation (product code KIC), Class I - General Controls.

Submitted by Medical Industries America, Inc. (Australia 2038, AU). The FDA issued a Cleared decision on November 14, 1986 after a review of 24 days - a notably fast clearance cycle.

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: 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 Medical Industries America, Inc. devices

Submission Details

510(k) Number K864108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1986
Decision Date November 14, 1986
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
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.