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510(k) K112944

FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES by Fresenius Medical Care South Asia Pacific Pty , Ltd. — Product Code INO

K112944 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care South Asia Pacific Pty , Ltd. for the device "FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES". The FDA issued a decision of Substantially Equivalent on December 30, 2011. The device falls under product code INO (Chair, Positioning, Electric), a Class II device regulated under 21 CFR 890.3110. Fresenius Medical Care South Asia Pacific Pty , Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2011
Date Received
October 4, 2011
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 Fresenius Medical Care South Asia Pacific Pty , Ltd.

  • K091727 — MEDICAL TREATMENT CHAIR, T400, T500,T600 (July 6, 2009)

Other clearances for product code INO

  • K131909 — DALTON LIFT CHAIR (February 24, 2014)
  • K123834 — EASYSTAND BANTAM MEDIUM (August 13, 2013)
  • K101723 — COMPACT WHEELCHAIR PLATFORM (December 23, 2010)
  • K091578 — LIFT CHAIR, MODEL T3 (December 2, 2009)
  • K091242 — BANTAM (July 6, 2009)
  • K091727 — MEDICAL TREATMENT CHAIR, T400, T500,T600 (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)
  • K071793 — CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR (August 3, 2007)

FDA data resources