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510(k) K813225

GEL FLOTATION CUSHION by Jefferson Industries, Inc. — Product Code KIC

K813225 is an FDA 510(k) premarket notification submitted by Jefferson Industries, Inc. for the device "GEL FLOTATION CUSHION". The FDA issued a decision of Substantially Equivalent on December 3, 1981. The device falls under product code KIC (Cushion, Flotation), a Class I device regulated under 21 CFR 890.3175. Jefferson Industries, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1981
Date Received
November 10, 1981
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 Jefferson Industries, Inc.

  • K813226 — GEL FLOTATION MATTRESS (December 2, 1981)
  • K802603 — ECONO-FLOAT WHEELCHAIR FLOTATION CUSHION (November 12, 1980)
  • K780779 — ECONO-FLOAT WATER FLOTATION MATTRESS (May 19, 1978)

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