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510(k) K880398

POWER TOILET ELEVATOR by Med-West, Inc. — Product Code INO

K880398 is an FDA 510(k) premarket notification submitted by Med-West, Inc. for the device "POWER TOILET ELEVATOR". The FDA issued a decision of Substantially Equivalent on March 17, 1988. The device falls under product code INO (Chair, Positioning, Electric), a Class II device regulated under 21 CFR 890.3110. Med-West, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1988
Date Received
January 29, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Positioning, Electric
Device Class
Class II
Regulation Number
890.3110
Review Panel
PM
Submission Type

Other clearances by Med-West, Inc.

  • K880877 — CONTRAST INJECTION DEVICE (May 31, 1988)
  • K874470 — MWI 400 WOUND DRESSING (December 18, 1987)
  • K872724 — SHEATH/DILATORS (September 15, 1987)
  • K854612 — ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7 (January 3, 1986)
  • K852162 — MNI 400 INJECTION CAPS (June 12, 1985)
  • K842342 — MWI 888 & 666 DOUBLE LUMEN SUBCLAVIAN (June 14, 1984)
  • K832124 — CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI (August 12, 1983)
  • K831828 — TEFLON FEMORAL CATHETER MWI 100,10 & (July 7, 1983)
  • K831401 — SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS (June 3, 1983)
  • K831440 — SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260 (June 3, 1983)

Other clearances for product code INO

  • K131909 — DALTON LIFT CHAIR (February 24, 2014)
  • K123834 — EASYSTAND BANTAM MEDIUM (August 13, 2013)
  • K112944 — FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES (December 30, 2011)
  • K101723 — COMPACT WHEELCHAIR PLATFORM (December 23, 2010)
  • K091578 — LIFT CHAIR, MODEL T3 (December 2, 2009)
  • K091727 — MEDICAL TREATMENT CHAIR, T400, T500,T600 (July 6, 2009)
  • K091242 — BANTAM (July 6, 2009)
  • K073565 — STANDARD WHEELCHAIR PLATFORM (February 6, 2009)
  • K081053 — PIVOT ASSIST (October 9, 2008)
  • K080533 — WINCO MODEL POWER SERIES LIFT CHAIR (August 11, 2008)

FDA data resources