Gentle-Lift Chair

FDA 510(k) K821827 · Pride Health Care Equipment

Substantially Equivalent

510(k) numberK821827

Submission

Device name
Gentle-Lift Chair
Applicant
Pride Health Care Equipment
Mchenry, IL, US
Received
June 22, 1982
Decision date
July 20, 1982
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

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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
K852864Gentle Lift-Recliner ChairINO · Traditional 09/24/1985SE

Questions and answers

When was Gentle-Lift Chair cleared by the FDA?

Gentle-Lift Chair (K821827) received a 510(k) decision of Substantially Equivalent on July 20, 1982, 28 days after the submission was received.

What is the product code of K821827?

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