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510(k) K822402

ROTO REST KINETIC TREATMENT TABLE PEDIA by Kinetic Concepts, Inc. — Product Code IKZ

K822402 is an FDA 510(k) premarket notification submitted by Kinetic Concepts, Inc. for the device "ROTO REST KINETIC TREATMENT TABLE PEDIA". The FDA issued a decision of Substantially Equivalent on October 22, 1982. The device falls under product code IKZ (Bed, Patient Rotation, Powered), a Class II device regulated under 21 CFR 890.5225. Kinetic Concepts, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1982
Date Received
August 10, 1982
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 Kinetic Concepts, Inc.

  • K050261 — V.A.C. GRANUFOAM SILVER PROTECTION DRESSING (May 26, 2005)
  • K041642 — V.A.C. GRANUFOAM SILVER DRESSING (January 25, 2005)
  • K032310 — MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS (October 10, 2003)
  • K022011 — V.A.C. ABDOMINAL DRESSING (February 26, 2003)
  • K021500 — VACUUM ASSISTED CLOSURE (December 20, 2002)
  • K021501 — V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT (December 2, 2002)
  • K020781 — WET CHAMBER (May 6, 2002)
  • K992448 — V.A.C. PLUS (January 18, 2000)
  • K972176 — HOME CARE BEAD BED (January 16, 1998)
  • K972549 — SIMPULSE (November 18, 1997)

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