Bantam

FDA 510(k) K091242 · Altimate Medical, Inc.

Substantially Equivalent

510(k) numberK091242

Submission

Device name
Bantam
Applicant
Altimate Medical, Inc.
Elyria, OH, US
Received
April 28, 2009
Decision date
July 6, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 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

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
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
K071793Convertible I-Series Positioning and Transfer ChairINO · Traditional Barton Medical Corp.08/03/2007SE

More from Barton Medical Corp.

510(k)DeviceDecision
K123834Easystand Bantam MediumINO · Traditional 08/13/2013SE

Questions and answers

When was Bantam cleared by the FDA?

Bantam (K091242) received a 510(k) decision of Substantially Equivalent on July 6, 2009, 69 days after the submission was received.

What is the product code of K091242?

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