Finger Extension Splint
FDA 510(k) K823647 · Fred Sammons, Inc.
510(k) numberK823647
Submission
- Device name
- Finger Extension Splint
- Applicant
- Fred Sammons, Inc.
Mchenry, IL, US - Received
- December 6, 1982
- Decision date
- January 21, 1983
- 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 |
| 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 |
| K823165 | Wrist Spling & Forearm SplintILH · Traditional | Warm & Form, Orthopedic Materials | 11/16/1982SE |
| 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 |
|---|---|---|
| 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 Finger Extension Splint cleared by the FDA?
Finger Extension Splint (K823647) received a 510(k) decision of Substantially Equivalent on January 21, 1983, 46 days after the submission was received.
What is the product code of K823647?
The FDA product code is ILH – Splint, Hand, And Components, a Class I (low risk) device regulated under 21 CFR 890.3475.