Arm Through for Wheelchair BK-6459-01 &
FDA 510(k) K823636 · Fred Sammons, Inc.
510(k) numberK823636
Submission
- Device name
- Arm Through for Wheelchair BK-6459-01 &
- Applicant
- Fred Sammons, Inc.
Mchenry, IL, US - Received
- December 6, 1982
- Decision date
- December 28, 1982
- 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 |
| K823816 | Wheelchair Patient RestraintsKNO · Traditional | Danek Medical, Inc. | 01/14/1983SE |
| 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 |
|---|---|---|
| K880644 | Ultra-Pan for Orthotic Plastics (7262)IRQ · Traditional | 05/06/1988SE |
| K880647 | Adult Perceptual Motor Puzzles (5331-01)HOX · Traditional | 04/01/1988SE |
| K831549 | Arm SlingsILI · Traditional | 06/30/1983SE |
| K831548 | SplintsILH · Traditional | 06/27/1983SE |
| K831550 | Finger Boniometer BK7506KQW · Traditional | 06/24/1983SE |
| K831544 | Deluxe Traction Exercise Glove BK5035IOD · Traditional | 06/24/1983SE |
| K831543 | Adjust. WEIGHTS-BK5171-05,10,20 BeokION · Traditional | 06/24/1983SE |
| K831542 | Adjustable Polycentric Elbow HingeIQI · Traditional | 06/24/1983SE |
| K831553 | Leg Drainage Bag Strap BK6011KNX · Traditional | 06/16/1983SE |
| K831552 | Sorbothane Visco Inner Sole PadKNP · Traditional | 06/08/1983SE |
Questions and answers
When was Arm Through for Wheelchair BK-6459-01 & cleared by the FDA?
Arm Through for Wheelchair BK-6459-01 & (K823636) received a 510(k) decision of Substantially Equivalent on December 28, 1982, 22 days after the submission was received.
What is the product code of K823636?
The FDA product code is KNO – Accessories, Wheelchair, a Class I (low risk) device regulated under 21 CFR 890.3910.