Solid Wood Cone
FDA 510(k) K823600 · Fred Sammons, Inc.
510(k) numberK823600
Submission
- Device name
- Solid Wood Cone
- Applicant
- Fred Sammons, Inc.
Mchenry, IL, US - Received
- December 6, 1982
- Decision date
- December 22, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IOD – Components, Exercise
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5350
- Specialty
- Physical Medicine
Other 510(k)s with product code IOD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K831544 | Deluxe Traction Exercise Glove BK5035IOD · Traditional | Fred Sammons, Inc. | 06/24/1983SE |
| K823648 | Surgical TubingIOD · Traditional | Fred Sammons, Inc. | 01/21/1983SE |
| K823822 | Ankle WeightsIOD · Traditional | Danek Medical, Inc. | 01/14/1983SE |
| K813632 | Color Coded Weight CuffsIOD · Traditional | Fred Sammons, Inc. | 01/19/1982SE |
| K812319 | Therapy BenchIOD · Traditional | Kaye Products, Inc. | 08/31/1981SE |
| K790587 | Canvas WedgeIOD · Traditional | Maddak, Inc. | 04/03/1979SE |
| K772414 | Sandbags, Various WeightsIOD · Traditional | Fred Sammons, Inc. | 02/01/1978SE |
| K771030 | Flexion MittensIOD · Traditional | Stat Medical Corp. | 06/27/1977SE |
| K761119 | Sheet Metal ClampIOD · Traditional | Fred Sammons, Inc. | 12/02/1976SE |
| K761118 | Hand Screw ClampIOD · Traditional | Fred Sammons, Inc. | 12/02/1976SE |
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 Solid Wood Cone cleared by the FDA?
Solid Wood Cone (K823600) received a 510(k) decision of Substantially Equivalent on December 22, 1982, 16 days after the submission was received.
What is the product code of K823600?
The FDA product code is IOD – Components, Exercise, a Class I (low risk) device regulated under 21 CFR 890.5350.