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510(k) K813226

GEL FLOTATION MATTRESS by Jefferson Industries, Inc. — Product Code IKY

K813226 is an FDA 510(k) premarket notification submitted by Jefferson Industries, Inc. for the device "GEL FLOTATION MATTRESS". The FDA issued a decision of Substantially Equivalent on December 2, 1981. The device falls under product code IKY (Mattress, Flotation Therapy, Non-Powered), a Class I device regulated under 21 CFR 880.5150. Jefferson Industries, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1981
Date Received
November 10, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mattress, Flotation Therapy, Non-Powered
Device Class
Class I
Regulation Number
880.5150
Review Panel
HO
Submission Type

Other clearances by Jefferson Industries, Inc.

  • K813225 — GEL FLOTATION CUSHION (December 3, 1981)
  • K802603 — ECONO-FLOAT WHEELCHAIR FLOTATION CUSHION (November 12, 1980)
  • K780779 — ECONO-FLOAT WATER FLOTATION MATTRESS (May 19, 1978)

Other clearances for product code IKY

  • K914921 — SCM-3 AND ACCESSORIES (March 12, 1992)
  • K802833 — TETRA NATAL-MAT WATER FLOTATION MAT. (December 10, 1980)
  • K802781 — BEDDING PADS EGGCREATE PADS (December 10, 1980)
  • K780779 — ECONO-FLOAT WATER FLOTATION MATTRESS (May 19, 1978)
  • K772062 — NEONATAL FLOTATION SYSTEM (November 15, 1977)
  • K771824 — MEDPRO FLOTATION SYSTEM (October 19, 1977)
  • K760963 — DECUBITUS MATTRESS (November 18, 1976)

FDA data resources