Convalescent Recliner
FDA 510(k) K802803 · Winfield Co., Inc.
510(k) numberK802803
Submission
- Device name
- Convalescent Recliner
- Applicant
- Winfield Co., Inc.
Mchenry, IL, US - Received
- November 3, 1980
- Decision date
- November 19, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K101723 | Compact Wheelchair PlatformINO · Traditional | Design Specific Fletcher | 12/23/2010SE |
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| 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 |
More from Winco, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K942902 | Sharps-Tainer Small Opening W/Needle RemoverMMK · Traditional | 12/15/1994SE |
| K942903 | Sharps-Tainer Small OpeningFMI · Traditional | 09/19/1994SE |
| K942901 | Sharps-Tainer Large OpeningFMI · Traditional | 09/19/1994SE |
| K891855 | Winfield Latex Examination GlovesLYY · Traditional | 06/22/1989SE |
Questions and answers
When was Convalescent Recliner cleared by the FDA?
Convalescent Recliner (K802803) received a 510(k) decision of Substantially Equivalent on November 19, 1980, 16 days after the submission was received.
What is the product code of K802803?
The FDA product code is INO – Chair, Positioning, Electric, a Class II (moderate risk) device regulated under 21 CFR 890.3110.