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510(k) K933964

THE CRADLE by The Primal Energy Research Foundation — Product Code IKZ

K933964 is an FDA 510(k) premarket notification submitted by The Primal Energy Research Foundation for the device "THE CRADLE". The FDA issued a decision of Substantially Equivalent on October 3, 1994. 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
October 3, 1994
Date Received
August 16, 1993
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)
  • 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)
  • K905113 — ROTO REST; TRAUMA AND INTENSIVE CARE BED (November 26, 1990)

FDA data resources