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510(k) K945667

MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION by Micos Medical Systems — Product Code KIC

K945667 is an FDA 510(k) premarket notification submitted by Micos Medical Systems for the device "MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION". The FDA issued a decision of Substantially Equivalent on February 21, 1995. The device falls under product code KIC (Cushion, Flotation), a Class I device regulated under 21 CFR 890.3175. Micos Medical Systems has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1995
Date Received
November 17, 1994
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 Micos Medical Systems

  • K945845 — MICOS MICROPULSE(TM) OR TABLE PATIENT SUPPORT (May 3, 1995)
  • K945629 — MICOS MICROPULSE(TM) ALTERNATING PRESSURE MATTRESS (April 14, 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)
  • 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