Penox Lift Chair

FDA 510(k) K851218 · Penox Technologies, Inc.

Substantially Equivalent

510(k) numberK851218

Submission

Device name
Penox Lift Chair
Applicant
Penox Technologies, Inc.
Pittston, PA, US
Received
March 26, 1985
Decision date
June 21, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
INO – Chair, Positioning, Electric
Device class
Class II (moderate risk)
Regulation
21 CFR 890.3110
Specialty
Physical Medicine

Other 510(k)s with product code INO

510(k)DeviceApplicantDecision
K131909Dalton Lift ChairINO · Traditional Dalton Instrument Corp.02/24/2014SE
K123834Easystand Bantam MediumINO · Traditional Altimate Medical, Inc.08/13/2013SE
K112944Fresenius Medical Treatment Chair T688 SeriesINO · Traditional Fresenius Medical Care South Asia Pacific Pty…12/30/2011SE
K101723Compact Wheelchair PlatformINO · Traditional Design Specific Fletcher12/23/2010SE
K091578Lift Chair, Model T3INO · Special Pride Mobility Products Corp.12/02/2009SE
K091727Medical Treatment Chair, T400, T500,T600INO · Traditional Fresenius Medical Care South Asia Pacific Pty…07/06/2009SE
K091242BantamINO · Traditional Altimate Medical, Inc.07/06/2009SE
K073565Standard Wheelchair PlatformINO · Traditional Design Specific , Ltd.02/06/2009SE
K081053Pivot AssistINO · Traditional Pivot Assist, LLC10/09/2008SE
K080533Winco Model Power Series Lift ChairINO · Traditional Winco, Inc.08/11/2008SE

More from Winco, Inc.

510(k)DeviceDecision
K864667Penox Hospital BedFNJ · Traditional 01/21/1987SE
K863978Portable Liquid Oxygen Unit (Modification)BYJ · Traditional 12/15/1986SE
K862654Modified Penox Lift ChairINO · Traditional 07/18/1986SE
K853775Penox High Flow ManifoldBYJ · Traditional 11/29/1985SE
K852109Penox Performer WheelchairIOR · Traditional 08/22/1985SE
K851219Fill Hose Safety AdapterCAM · Traditional 06/18/1985SE
K851217Penox Dual Flow MinifoldCAM · Traditional 06/18/1985SE
K851216Penox Dual Feed ManifoldCAM · Traditional 06/18/1985SE
K851215T-Handle Adapter, U-Handle & L Handler AdapterCAM · Traditional 06/18/1985SE

Questions and answers

When was Penox Lift Chair cleared by the FDA?

Penox Lift Chair (K851218) received a 510(k) decision of Substantially Equivalent on June 21, 1985, 87 days after the submission was received.

What is the product code of K851218?

The FDA product code is INO – Chair, Positioning, Electric, a Class II (moderate risk) device regulated under 21 CFR 890.3110.