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510(k) K960189

GEL-T CUSHION by Span-America Medical Systems, Inc. — Product Code KIC

K960189 is an FDA 510(k) premarket notification submitted by Span-America Medical Systems, Inc. for the device "GEL-T CUSHION". The FDA issued a decision of Substantially Equivalent on February 7, 1996. The device falls under product code KIC (Cushion, Flotation), a Class I device regulated under 21 CFR 890.3175. Span-America Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1996
Date Received
January 16, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cushion, Flotation
Device Class
Class I
Regulation Number
890.3175
Review Panel
PM
Submission Type

Other clearances by Span-America Medical Systems, Inc.

  • K973169 — PRESSURE GUARD SITE SELECT (A) (February 20, 1998)
  • K972486 — PRESSUREGUARD IV (February 20, 1998)
  • K960188 — PRESSUREGUARD: SELECTCARE (October 2, 1996)
  • K961502 — LUBRICATING JELLY, LOW VISCOSITY (July 18, 1996)
  • K961159 — POWERED LOW AIR LOSS MATTRESS SYSTEM (June 14, 1996)
  • K960620 — PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM (April 25, 1996)
  • K954766 — PRESSURE GUARD ALTERNATING PRESSURE MATTRESS (January 11, 1996)
  • K953503 — PRESSUREGUARD IV (October 24, 1995)
  • K954117 — CUSTOMCARE SEATING SYSTEM (October 13, 1995)
  • K951112 — PRESSUREGUARD IV (June 6, 1995)

Other clearances for product code KIC

  • K953352 — PROTEAM CUSHION (November 29, 1995)
  • K954117 — CUSTOMCARE SEATING SYSTEM (October 13, 1995)
  • K950085 — MULTICURE(R) S GEL PAD (July 13, 1995)
  • K945667 — MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION (February 21, 1995)
  • K941858 — GEL CUSHION (May 5, 1994)
  • K911843 — ZERO-G(TM) GEL/FOAM MATTRESS TOPPER (May 30, 1991)
  • K872739 — SAFE-SEAT, LOW-PROFILE WHEELCHAIR CUSHION (July 30, 1987)
  • K864109 — C' AIRECUSH SEAT CUSHION (November 14, 1986)
  • K864108 — PUSH CUSH (November 14, 1986)
  • K861327 — ROHO HEEL PAD (June 2, 1986)

FDA data resources