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510(k) K802781

BEDDING PADS EGGCREATE PADS by Leemart Bedding Mfg. Co. — Product Code IKY

K802781 is an FDA 510(k) premarket notification submitted by Leemart Bedding Mfg. Co. for the device "BEDDING PADS EGGCREATE PADS". The FDA issued a decision of Substantially Equivalent on December 10, 1980. The device falls under product code IKY (Mattress, Flotation Therapy, Non-Powered), a Class I device regulated under 21 CFR 880.5150.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1980
Date Received
November 5, 1980
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 for product code IKY

  • K914921 — SCM-3 AND ACCESSORIES (March 12, 1992)
  • K813226 — GEL FLOTATION MATTRESS (December 2, 1981)
  • K802833 — TETRA NATAL-MAT WATER FLOTATION MAT. (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