Prevent I
FDA 510(k) K973373 · The Buzzz Corp.
510(k) numberK973373
Submission
- Device name
- Prevent I
- Applicant
- The Buzzz Corp.
Larksville, PA, US - Received
- September 8, 1997
- Decision date
- February 26, 1998
- 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
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|---|---|---|---|
| K131909 | Dalton Lift ChairINO · Traditional | Dalton Instrument Corp. | 02/24/2014SE |
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| 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 |
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Questions and answers
When was Prevent I cleared by the FDA?
Prevent I (K973373) received a 510(k) decision of Substantially Equivalent on February 26, 1998, 171 days after the submission was received.
What is the product code of K973373?
The FDA product code is INO – Chair, Positioning, Electric, a Class II (moderate risk) device regulated under 21 CFR 890.3110.