Merits Model E Series Lift Chairs

FDA 510(k) K060212 · Merits Health Products Co., Ltd.

Substantially Equivalent

510(k) numberK060212

Submission

Device name
Merits Model E Series Lift Chairs
Applicant
Merits Health Products Co., Ltd.
Taichung, TW
Received
January 27, 2006
Decision date
March 7, 2006
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

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

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K101723Compact Wheelchair PlatformINO · Traditional Design Specific Fletcher12/23/2010SE
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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

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Questions and answers

When was Merits Model E Series Lift Chairs cleared by the FDA?

Merits Model E Series Lift Chairs (K060212) received a 510(k) decision of Substantially Equivalent on March 7, 2006, 39 days after the submission was received.

What is the product code of K060212?

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