Cleared Traditional

K954117 - CUSTOMCARE SEATING SYSTEM

K954117 is an FDA 510(k) clearance for CUSTOMCARE SEATING SYSTEM, manufactured by Span-America Medical Systems, Inc.. The device is a Class 1 Physical Medicine device with product code KIC cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K954117 · Span-America Medical Systems, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K954117

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 116d · This submission: 42d
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 28
Devices cleared under the same product code (KIC) and FDA review panel - the closest regulatory comparables to K954117.
GEL-T CUSHION
K960189 · Span-America Medical Systems, Inc. · Feb 1996
PROTEAM CUSHION
K953352 · Iskra.Med · Nov 1995
MULTICURE(R) S GEL PAD
K950085 · Multigestion (Deutschland) GmbH · Jul 1995
MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION
K945667 · Micos Medical Systems · Feb 1995
GEL CUSHION
K941858 · Hollister, Inc. · May 1994
ZERO-G(TM) GEL/FOAM MATTRESS TOPPER
K911843 · Steridyne Corp. · May 1991
K954117 · CUSTOMCARE SEATING SYSTEM
Download PDF FDA Summary Span-America Medical …