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510(k) K831247

SAFE-SEAT WHEELCHAIR CUSHION by D.A. Schulman, Inc. — Product Code KIC

K831247 is an FDA 510(k) premarket notification submitted by D.A. Schulman, Inc. for the device "SAFE-SEAT WHEELCHAIR CUSHION". The FDA issued a decision of Substantially Equivalent on May 16, 1983. The device falls under product code KIC (Cushion, Flotation), a Class I device regulated under 21 CFR 890.3175. D.A. Schulman, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1983
Date Received
April 18, 1983
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 D.A. Schulman, Inc.

  • K883681 — DAS SPORT PUMP(TM) (September 30, 1988)
  • K872739 — SAFE-SEAT, LOW-PROFILE WHEELCHAIR CUSHION (July 30, 1987)
  • K855004 — SWELL-RELIEF (February 12, 1986)

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