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510(k) K873047

KEANE MOBILITY BED by Surgi-Med, Inc. — Product Code IKZ

K873047 is an FDA 510(k) premarket notification submitted by Surgi-Med, Inc. for the device "KEANE MOBILITY BED". The FDA issued a decision of Substantially Equivalent on October 15, 1987. The device falls under product code IKZ (Bed, Patient Rotation, Powered), a Class II device regulated under 21 CFR 890.5225. Surgi-Med, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1987
Date Received
August 4, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Patient Rotation, Powered
Device Class
Class II
Regulation Number
890.5225
Review Panel
PM
Submission Type

Other clearances by Surgi-Med, Inc.

  • K881705 — MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM (July 13, 1988)
  • K872923 — PARAGON 9000 TILT AND TURN BED (October 14, 1987)
  • K872924 — PARAGON 8500 CARDIO-PULMONARY BED (October 9, 1987)
  • K872925 — MEGABED 1000 (September 15, 1987)

Other clearances for product code IKZ

  • K972486 — PRESSUREGUARD IV (February 20, 1998)
  • K972111 — RUMORS DYNAMIC AIR THERAPY UNIT (February 2, 1998)
  • K962788 — CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM (April 30, 1997)
  • K954671 — THE FREEDOM BED (April 1, 1996)
  • K950756 — PULMONEX DYNAMIC AIR THERAPY UNIT (May 30, 1995)
  • K950681 — MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY (May 16, 1995)
  • K933964 — THE CRADLE (October 3, 1994)
  • K923710 — OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED (March 22, 1993)
  • K922473 — TURN EZ BED DEVICE (September 9, 1992)
  • K905390 — KUDO (POWERED ROTATION BED) (January 8, 1991)

FDA data resources