United #1018-FREEDOM Series, United #2018-COMFORT Series, United #3018-ELEGANCE Series, United #5018-MASTER Series
FDA 510(k) K002318 · United Chair Mfg., LLC
510(k) numberK002318
Submission
- Device name
- United #1018-FREEDOM Series, United #2018-COMFORT Series, United #3018-ELEGANCE Series, United #5018-MASTER Series
- Applicant
- United Chair Mfg., LLC
Columbus, OH, US - Received
- July 31, 2000
- Decision date
- October 11, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K131909 | Dalton Lift ChairINO · Traditional | Dalton Instrument Corp. | 02/24/2014SE |
| K123834 | Easystand Bantam MediumINO · Traditional | Altimate Medical, Inc. | 08/13/2013SE |
| K112944 | Fresenius Medical Treatment Chair T688 SeriesINO · Traditional | Fresenius Medical Care South Asia Pacific Pty… | 12/30/2011SE |
| 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 |
Questions and answers
When was United #1018-FREEDOM Series, United #2018-COMFORT Series, United #3018-ELEGANCE Series, United #5018-MASTER Series cleared by the FDA?
United #1018-FREEDOM Series, United #2018-COMFORT Series, United #3018-ELEGANCE Series, United #5018-MASTER Series (K002318) received a 510(k) decision of Substantially Equivalent on October 11, 2000, 72 days after the submission was received.
What is the product code of K002318?
The FDA product code is INO – Chair, Positioning, Electric, a Class II (moderate risk) device regulated under 21 CFR 890.3110.