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510(k) K844025

CONTOUR CHAIR LOUNGE W/OPTIIONAL HEAT & MASSAGE by Craftmatic/Contour Organization, Inc. — Product Code INO

K844025 is an FDA 510(k) premarket notification submitted by Craftmatic/Contour Organization, Inc. for the device "CONTOUR CHAIR LOUNGE W/OPTIIONAL HEAT & MASSAGE". The FDA issued a decision of Substantially Equivalent on January 17, 1985. The device falls under product code INO (Chair, Positioning, Electric), a Class II device regulated under 21 CFR 890.3110. Craftmatic/Contour Organization, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1985
Date Received
October 15, 1984
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 Craftmatic/Contour Organization, Inc.

  • K880861 — MECHANICAL ADJUSTABLE CHAIR (AC POWERED) (March 17, 1988)

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