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510(k) K914851

CLA-1400 SYSTEM by Gaymar Industries, Inc. — Product Code IOQ

K914851 is an FDA 510(k) premarket notification submitted by Gaymar Industries, Inc. for the device "CLA-1400 SYSTEM". The FDA issued a decision of Substantially Equivalent on November 13, 1991. The device falls under product code IOQ (Bed, Flotation Therapy, Powered), a Class II device regulated under 21 CFR 890.5170. Gaymar Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1991
Date Received
October 28, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Flotation Therapy, Powered
Device Class
Class II
Regulation Number
890.5170
Review Panel
PM
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)
  • K914921 — SCM-3 AND ACCESSORIES (March 12, 1992)
  • K914805 — TC-1000, TC-1050 SYSTEM (January 7, 1992)
  • K912051 — MEDI-THERM (MTA-5900) & DETACHABLE HOSES (July 30, 1991)

Other clearances for product code IOQ

  • K143414 — Hill-Rom Wireless Connectivity Module (March 10, 2015)
  • K122473 — TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE (June 3, 2013)
  • K973624 — NURSE'S AID PATIENT ROTATION SYSTEM (January 21, 1998)
  • K970363 — HYDROTEC LOW AIR LOSS THERAPY BED (November 17, 1997)
  • K970364 — AIRTEC2 LOW AIR LOSS THERAPY BED (November 17, 1997)
  • K970636 — TOTALCARE., MODULAR THERAPY SYSTEM (MTS) (August 26, 1997)
  • K964873 — SILKAIR LOW AIRLOSS THERAPY (July 3, 1997)
  • K970295 — FLEXICAIR EXLIPSE PLUS (May 16, 1997)
  • K943433 — TOTAL CONTACT SEAT RIPPLE SYSTEM (July 31, 1995)
  • K951001 — FLEXICAIR EXLIPSE (June 27, 1995)

FDA data resources