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510(k) K002318

UNITED #1018-FREEDOM SERIES, UNITED #2018-COMFORT SERIES, UNITED #3018-ELEGANCE SERIES, UNITED #5018-MASTER SERIES by United Chair Mfg., LLC — Product Code INO

K002318 is an FDA 510(k) premarket notification submitted by United Chair Mfg., LLC for the device "UNITED #1018-FREEDOM SERIES, UNITED #2018-COMFORT SERIES, UNITED #3018-ELEGANCE SERIES, UNITED #5018-MASTER SERIES". The FDA issued a decision of Substantially Equivalent on October 11, 2000. 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 11, 2000
Date Received
July 31, 2000
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

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  • 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