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510(k) K862654

MODIFIED PENOX LIFT CHAIR by Penox Technologies, Inc. — Product Code INO

K862654 is an FDA 510(k) premarket notification submitted by Penox Technologies, Inc. for the device "MODIFIED PENOX LIFT CHAIR". The FDA issued a decision of Substantially Equivalent on July 18, 1986. The device falls under product code INO (Chair, Positioning, Electric), a Class II device regulated under 21 CFR 890.3110. Penox Technologies, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1986
Date Received
July 11, 1986
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 Penox Technologies, Inc.

  • K864667 — PENOX HOSPITAL BED (January 21, 1987)
  • K863978 — PORTABLE LIQUID OXYGEN UNIT (MODIFICATION) (December 15, 1986)
  • K853775 — PENOX HIGH FLOW MANIFOLD (November 29, 1985)
  • K852109 — PENOX PERFORMER WHEELCHAIR (August 22, 1985)
  • K851218 — PENOX LIFT CHAIR (June 21, 1985)
  • K851219 — FILL HOSE SAFETY ADAPTER (June 18, 1985)
  • K851216 — PENOX DUAL FEED MANIFOLD (June 18, 1985)
  • K851215 — T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER (June 18, 1985)
  • K851217 — PENOX DUAL FLOW MINIFOLD (June 18, 1985)

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