Wheelchair Patient Restraints
FDA 510(k) K823816 · Danek Medical, Inc.
510(k) numberK823816
Submission
- Device name
- Wheelchair Patient Restraints
- Applicant
- Danek Medical, Inc.
Mchenry, IL, US - Received
- December 17, 1982
- Decision date
- January 14, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNO – Accessories, Wheelchair
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3910
- Specialty
- Physical Medicine
Other 510(k)s with product code KNO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K870298 | Redman AccessoriesKNO · Traditional | Redman, Inc. | 02/26/1987SE |
| K823646 | Friction FeederKNO · Traditional | Fred Sammons, Inc. | 01/21/1983SE |
| K823645 | Velcro Straps to Hold Arm to WheelchairKNO · Traditional | Fred Sammons, Inc. | 01/21/1983SE |
| K823636 | Arm Through for Wheelchair BK-6459-01 &KNO · Traditional | Fred Sammons, Inc. | 12/28/1982SE |
| K823635 | Cushions for Wheelchair ArmsKNO · Traditional | Fred Sammons, Inc. | 12/28/1982SE |
| K823596 | Clamp on Holder for a Glass or CupKNO · Traditional | Fred Sammons, Inc. | 12/22/1982SE |
| K823595 | Head Support for WheelchairKNO · Traditional | Fred Sammons, Inc. | 12/22/1982SE |
| K821642 | Wheel Chair AccessoriesKNO · Traditional | Fred Sammons, Inc. | 06/11/1982SE |
| K820964 | Wheelchair PalKNO · Traditional | Pryor Products | 04/16/1982SE |
| K813627 | BK-6453 Rimmed Acrylic Lap Tray KitKNO · Traditional | Fred Sammons, Inc. | 01/19/1982SE |
More from Fred Sammons, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K994122 | Bone Graft Washer, Model 9090114 - 9090118KWQ · Traditional | 02/18/2000SE |
| K993810 | CD Horizon Spinal SystemMNH · Special | 02/03/2000SE |
| K993855 | Atlantis Anterior Cervical Plate SystemKWQ · Special | 12/15/1999SE |
| K991528 | Modification to Tenor Spinal System-Rod/Bolt ConnectorMNH · Special | 05/28/1999SE |
| K990603 | Modification of the Zplate-Atl Anterior Fixation SystemKWQ · Special | 03/10/1999SE |
| K982875 | Modification to Zplate-Atl Anterior Fixation SystemKWQ · Special | 01/19/1999SE |
| K984522 | Modification of TSRH Spinal SystemMNI · Special | 01/06/1999SE |
| K982154 | Modification of Townley Pedicle Screw Plating SystemMNI · Special | 07/13/1998SE |
| K970599 | Townley Pedicle Screw Plating SystemMNI · Traditional | 03/20/1998SE |
| K943827 | Spine FixationMNH · Traditional | 02/14/1996SN |
Questions and answers
When was Wheelchair Patient Restraints cleared by the FDA?
Wheelchair Patient Restraints (K823816) received a 510(k) decision of Substantially Equivalent on January 14, 1983, 28 days after the submission was received.
What is the product code of K823816?
The FDA product code is KNO – Accessories, Wheelchair, a Class I (low risk) device regulated under 21 CFR 890.3910.