Fresenius Medical Treatment Chair T688 Series
FDA 510(k) K112944 · Fresenius Medical Care South Asia Pacific Pty , Ltd.
510(k) numberK112944
Submission
- Device name
- Fresenius Medical Treatment Chair T688 Series
- Applicant
- Fresenius Medical Care South Asia Pacific Pty , Ltd.
Milsons Point,, AU - Received
- October 4, 2011
- Decision date
- December 30, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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|---|---|---|---|
| K131909 | Dalton Lift ChairINO · Traditional | Dalton Instrument Corp. | 02/24/2014SE |
| K123834 | Easystand Bantam MediumINO · Traditional | Altimate Medical, Inc. | 08/13/2013SE |
| K101723 | Compact Wheelchair PlatformINO · Traditional | Design Specific Fletcher | 12/23/2010SE |
| K091578 | Lift Chair, Model T3INO · Special | Pride Mobility Products Corp. | 12/02/2009SE |
| K091727 | Medical Treatment Chair, T400, T500,T600INO · Traditional | Fresenius Medical Care South Asia Pacific Pty… | 07/06/2009SE |
| K091242 | BantamINO · Traditional | Altimate Medical, Inc. | 07/06/2009SE |
| K073565 | Standard Wheelchair PlatformINO · Traditional | Design Specific , Ltd. | 02/06/2009SE |
| K081053 | Pivot AssistINO · Traditional | Pivot Assist, LLC | 10/09/2008SE |
| K080533 | Winco Model Power Series Lift ChairINO · Traditional | Winco, Inc. | 08/11/2008SE |
| K071793 | Convertible I-Series Positioning and Transfer ChairINO · Traditional | Barton Medical Corp. | 08/03/2007SE |
More from Barton Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K091727 | Medical Treatment Chair, T400, T500,T600INO · Traditional | 07/06/2009SE |
Questions and answers
When was Fresenius Medical Treatment Chair T688 Series cleared by the FDA?
Fresenius Medical Treatment Chair T688 Series (K112944) received a 510(k) decision of Substantially Equivalent on December 30, 2011, 87 days after the submission was received.
What is the product code of K112944?
The FDA product code is INO – Chair, Positioning, Electric, a Class II (moderate risk) device regulated under 21 CFR 890.3110.