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510(k) K780779

ECONO-FLOAT WATER FLOTATION MATTRESS by Jefferson Industries, Inc. — Product Code IKY

K780779 is an FDA 510(k) premarket notification submitted by Jefferson Industries, Inc. for the device "ECONO-FLOAT WATER FLOTATION MATTRESS". The FDA issued a decision of Substantially Equivalent on May 19, 1978. 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
May 19, 1978
Date Received
May 11, 1978
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)
  • K813226 — GEL FLOTATION MATTRESS (December 2, 1981)
  • K802603 — ECONO-FLOAT WHEELCHAIR FLOTATION CUSHION (November 12, 1980)

Other clearances for product code IKY

  • K914921 — SCM-3 AND ACCESSORIES (March 12, 1992)
  • K813226 — GEL FLOTATION MATTRESS (December 2, 1981)
  • K802781 — BEDDING PADS EGGCREATE PADS (December 10, 1980)
  • K802833 — TETRA NATAL-MAT WATER FLOTATION MAT. (December 10, 1980)
  • K772062 — NEONATAL FLOTATION SYSTEM (November 15, 1977)
  • K771824 — MEDPRO FLOTATION SYSTEM (October 19, 1977)
  • K760963 — DECUBITUS MATTRESS (November 18, 1976)

FDA data resources