Cleared Traditional

CUSTOMCARE SEATING SYSTEM (K954117) - FDA 510(k) Clearance

Class I Physical Medicine device.

K954117 · Span-America Medical Systems, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
42d
Days
Class 1
Risk

K954117 is an FDA 510(k) clearance for the CUSTOMCARE SEATING SYSTEM. Classified as Cushion, Flotation (product code KIC), Class I - General Controls.

Submitted by Span-America Medical Systems, Inc. (Greenville, US). The FDA issued a Cleared decision on October 13, 1995 after a review of 42 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 Span-America Medical Systems, Inc. devices

Submission Details

510(k) Number K954117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1995
Decision Date October 13, 1995
Days to Decision 42 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 115d · This submission: 42d
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.