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510(k) K922473

TURN EZ BED DEVICE by Med-Ez, Inc. — Product Code IKZ

K922473 is an FDA 510(k) premarket notification submitted by Med-Ez, Inc. for the device "TURN EZ BED DEVICE". The FDA issued a decision of Substantially Equivalent on September 9, 1992. The device falls under product code IKZ (Bed, Patient Rotation, Powered), a Class II device regulated under 21 CFR 890.5225.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1992
Date Received
May 26, 1992
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 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)
  • K905390 — KUDO (POWERED ROTATION BED) (January 8, 1991)
  • K905113 — ROTO REST; TRAUMA AND INTENSIVE CARE BED (November 26, 1990)

FDA data resources