Cleared Traditional

MULTICURE(R) S GEL PAD (K950085) - FDA 510(k) Clearance

Class I Physical Medicine device.

K950085 · Multigestion (Deutschland) GmbH · Physical Medicine device
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Jul 1995
Decision
184d
Days
Class 1
Risk

K950085 is an FDA 510(k) clearance for the MULTICURE(R) S GEL PAD. Classified as Cushion, Flotation (product code KIC), Class I - General Controls.

Submitted by Multigestion (Deutschland) GmbH (Saint Victor De Gessieu, FR). The FDA issued a Cleared decision on July 13, 1995 after a review of 184 days - an extended review 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: 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 Multigestion (Deutschland) GmbH devices

Submission Details

510(k) Number K950085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1995
Decision Date July 13, 1995
Days to Decision 184 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
69d slower than avg
Panel avg: 115d · This submission: 184d
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.