577ES (Ergosense)
FDA 510(k) K945257 · Lumex, Inc.
510(k) numberK945257
Submission
- Device name
- 577ES (Ergosense)
- Applicant
- Lumex, Inc.
Bay Shore, NY, US - Received
- October 28, 1994
- Decision date
- April 26, 1995
- 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
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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 |
|---|---|---|
| K963674 | Lumex AirFNM · Traditional | 01/10/1997SE |
| K962123 | Akrotech 4000T Kinetic Turning Low Air Loss SystemFNM · Traditional | 07/18/1996SE |
| K953675 | AltadyneFNM · Traditional | 09/28/1995SE |
| K945175 | Mechanical Wheelchair 890.3850IOR · Traditional | 05/12/1995SE |
| K944574 | Lumex Wheelchairs (Ser. 1000, 3000, 4000, 5000, Tilt-In-Space, 6000, MRI)IOR · Traditional | 10/17/1994SE |
| K923977 | Akrotech 4000IOQ · Traditional | 02/12/1993SE |
| K895740 | Shower Chairs;Bed/Stretcher;Linen & Utility CartFPO · Traditional | 02/22/1990SE |
Questions and answers
When was 577ES (Ergosense) cleared by the FDA?
577ES (Ergosense) (K945257) received a 510(k) decision of Substantially Equivalent on April 26, 1995, 180 days after the submission was received.
What is the product code of K945257?
The FDA product code is INO – Chair, Positioning, Electric, a Class II (moderate risk) device regulated under 21 CFR 890.3110.