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510(k) K081053

PIVOT ASSIST by Pivot Assist, LLC — Product Code INO

K081053 is an FDA 510(k) premarket notification submitted by Pivot Assist, LLC for the device "PIVOT ASSIST". The FDA issued a decision of Substantially Equivalent on October 9, 2008. The device falls under product code INO (Chair, Positioning, Electric), a Class II device regulated under 21 CFR 890.3110.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2008
Date Received
April 14, 2008
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 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)
  • K091242 — BANTAM (July 6, 2009)
  • K091727 — MEDICAL TREATMENT CHAIR, T400, T500,T600 (July 6, 2009)
  • K073565 — STANDARD WHEELCHAIR PLATFORM (February 6, 2009)
  • K080533 — WINCO MODEL POWER SERIES LIFT CHAIR (August 11, 2008)
  • K071793 — CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR (August 3, 2007)

FDA data resources