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510(k) K864109

C' AIRECUSH SEAT CUSHION by Medical Industries America, Inc. — Product Code KIC

K864109 is an FDA 510(k) premarket notification submitted by Medical Industries America, Inc. for the device "C' AIRECUSH SEAT CUSHION". The FDA issued a decision of Substantially Equivalent on November 14, 1986. The device falls under product code KIC (Cushion, Flotation), a Class I device regulated under 21 CFR 890.3175. Medical Industries America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1986
Date Received
October 21, 1986
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 Medical Industries America, Inc.

  • K050990 — REMREST HEATED HUMIDIFIER (May 2, 2005)
  • K032170 — TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000 (May 28, 2004)
  • K002763 — REMREST (May 4, 2001)
  • K011053 — OPTIMA (April 20, 2001)
  • K964078 — 3050 SPORT-NEB (January 10, 1997)
  • K943990 — 3000 AEROSOL TWO (March 21, 1995)
  • K942444 — 3002 AEROMAX (March 10, 1995)
  • K941961 — 605 VACU-MAX (March 2, 1995)
  • K942208 — 4003 AEROLITE (February 24, 1995)
  • K940630 — 503 MAXI COMPRESSOR (February 21, 1995)

Other clearances for product code KIC

  • K960189 — GEL-T CUSHION (February 7, 1996)
  • 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)
  • K864108 — PUSH CUSH (November 14, 1986)
  • K861327 — ROHO HEEL PAD (June 2, 1986)

FDA data resources