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510(k) K914921

SCM-3 AND ACCESSORIES by Gaymar Industries, Inc. — Product Code IKY

K914921 is an FDA 510(k) premarket notification submitted by Gaymar Industries, Inc. for the device "SCM-3 AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on March 12, 1992. The device falls under product code IKY (Mattress, Flotation Therapy, Non-Powered), a Class I device regulated under 21 CFR 880.5150. Gaymar Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1992
Date Received
November 4, 1991
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 Gaymar Industries, Inc.

  • K100585 — MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 (January 20, 2011)
  • K073675 — T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP (May 8, 2008)
  • K962788 — CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM (April 30, 1997)
  • K963067 — SOF. PRESS EPC 51 SYSTEM (January 28, 1997)
  • K961854 — SPR PLUS II OVERLAY SYSTEM (CL250/CL212 (August 9, 1996)
  • K942881 — TC 3000 (May 23, 1995)
  • K930345 — TC2000 POWER UNIT AND ACCESSORIES (August 6, 1993)
  • K914805 — TC-1000, TC-1050 SYSTEM (January 7, 1992)
  • K914851 — CLA-1400 SYSTEM (November 13, 1991)
  • K912051 — MEDI-THERM (MTA-5900) & DETACHABLE HOSES (July 30, 1991)

Other clearances for product code IKY

  • 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)
  • 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