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510(k) K923710

OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED by Progressive Medical Technology, Inc. — Product Code IKZ

K923710 is an FDA 510(k) premarket notification submitted by Progressive Medical Technology, Inc. for the device "OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED". The FDA issued a decision of Substantially Equivalent on March 22, 1993. The device falls under product code IKZ (Bed, Patient Rotation, Powered), a Class II device regulated under 21 CFR 890.5225. Progressive Medical Technology, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1993
Date Received
July 27, 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 by Progressive Medical Technology, Inc.

  • K915638 — TALLEY TM200 INTERMTTENT COMPRESSION UNIT (February 11, 1992)
  • K915637 — TALLEY TM500 SEQUENTIAL MULTICOM COMPRESSION SYST. (February 11, 1992)
  • K915092 — TALLEY TM300 SEQUENTIAL MULTICOM COMPRESSION SYST (February 11, 1992)
  • K915671 — B.A.S.E. BELLOWS AIR SUPPORT EQUIPMENT (January 13, 1992)

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)
  • 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