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510(k) K851814

WHEELCHAIR CUSHIONS by Dignicare — Product Code KIC

K851814 is an FDA 510(k) premarket notification submitted by Dignicare for the device "WHEELCHAIR CUSHIONS". The FDA issued a decision of Substantially Equivalent on July 9, 1985. The device falls under product code KIC (Cushion, Flotation), a Class I device regulated under 21 CFR 890.3175.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1985
Date Received
April 26, 1985
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 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)
  • K864109 — C' AIRECUSH SEAT CUSHION (November 14, 1986)
  • K864108 — PUSH CUSH (November 14, 1986)

FDA data resources