Wrist Spling & Forearm Splint
FDA 510(k) K823165 · Warm & Form, Orthopedic Materials
510(k) numberK823165
Submission
- Device name
- Wrist Spling & Forearm Splint
- Applicant
- Warm & Form, Orthopedic Materials
Mchenry, IL, US - Received
- October 25, 1982
- Decision date
- November 16, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ILH – Splint, Hand, And Components
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3475
- Specialty
- Physical Medicine
Other 510(k)s with product code ILH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K832144 | Splint WoodILH · Traditional | Vermont Wood Industries, Inc. | 08/01/1983SE |
| K831548 | SplintsILH · Traditional | Fred Sammons, Inc. | 06/27/1983SE |
| K823647 | Finger Extension SplintILH · Traditional | Fred Sammons, Inc. | 01/21/1983SE |
| K823644 | Finger Flexion SplintILH · Traditional | Fred Sammons, Inc. | 01/21/1983SE |
| K823666 | Universal Wrist Splint & Forearm SplintILH · Traditional | Warm & Form, Orthopedic Materials | 12/30/1982SE |
| K823601 | Wrist SupportILH · Traditional | Fred Sammons, Inc. | 12/22/1982SE |
| K823393 | Stax Finger SplintsILH · Traditional | Orthopedic Systems, Inc. | 12/03/1982SE |
| K822651 | Total Finger Flexion SplintILH · Traditional | Alimed, Inc. | 09/17/1982SE |
| K821637 | Wire-Foam MP Flexion SpringILH · Traditional | Fred Sammons, Inc. | 06/11/1982SE |
| K821635 | Soft Ulnar Deviation SplintsILH · Traditional | Fred Sammons, Inc. | 06/11/1982SE |
More from Fred Sammons, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K830245 | Head HalterILZ · Traditional | 03/09/1983SE |
| K830244 | Traction AccessoriesHST · Traditional | 03/09/1983SE |
| K830243 | Abduction PillowIOZ · Traditional | 03/08/1983SE |
| K830246 | Cast Shoe, Cast BootJQB · Traditional | 02/18/1983SE |
| K823667 | Cervical CollarIQK · Traditional | 12/30/1982SE |
| K823666 | Universal Wrist Splint & Forearm SplintILH · Traditional | 12/30/1982SE |
| K823665 | Rotation BootKNP · Traditional | 12/30/1982SE |
| K823664 | Universal Sling, Sling & SwatheILI · Traditional | 12/30/1982SE |
| K823663 | Abdominal BinderKTD · Traditional | 12/30/1982SE |
| K823662 | Rib Belt (Universal)IPX · Traditional | 12/30/1982SE |
Questions and answers
When was Wrist Spling & Forearm Splint cleared by the FDA?
Wrist Spling & Forearm Splint (K823165) received a 510(k) decision of Substantially Equivalent on November 16, 1982, 22 days after the submission was received.
What is the product code of K823165?
The FDA product code is ILH – Splint, Hand, And Components, a Class I (low risk) device regulated under 21 CFR 890.3475.