Cleared Traditional

K953352 - PROTEAM CUSHION

K953352 is an FDA 510(k) clearance for PROTEAM CUSHION, manufactured by Iskra.Med. The device is a Class 1 Physical Medicine device with product code KIC cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K953352 · Iskra.Med · Physical Medicine device
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Nov 1995
Decision
135d
Days
Class 1
Risk

K953352 is an FDA 510(k) clearance for the PROTEAM CUSHION. Classified as Cushion, Flotation (product code KIC), Class I - General Controls.

Submitted by Iskra.Med (Great Neck,, US). The FDA issued a Cleared decision on November 29, 1995 after a review of 135 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 Iskra.Med devices

FDA 510(k) Submission Details - K953352

510(k) Number K953352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1995
Decision Date November 29, 1995
Days to Decision 135 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
20d slower than avg
Panel avg: 115d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

KIC Device Classification - Class 1, General Controls

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.

Regulatory Peers - KIC Cushion, Flotation

All 12
Devices cleared under the same product code (KIC) and FDA review panel - the closest regulatory comparables to K953352.
GEL-T CUSHION
K960189 · Span-America Medical Systems, Inc. · Feb 1996
CUSTOMCARE SEATING SYSTEM
K954117 · Span-America Medical Systems, Inc. · Oct 1995
GEL CUSHION
K941858 · Hollister, Inc. · May 1994
PUSH CUSH
K864108 · Medical Industries America, Inc. · Nov 1986
C' AIRECUSH SEAT CUSHION
K864109 · Medical Industries America, Inc. · Nov 1986
SOF. CARE CUSHION & SOF-CARE CUSHION COVER
K851027 · Gaymar Industries, Inc. · Jun 1985