Total Finger Flexion Splint
FDA 510(k) K822651 · Alimed, Inc.
510(k) numberK822651
Submission
- Device name
- Total Finger Flexion Splint
- Applicant
- Alimed, Inc.
Mchenry, IL, US - Received
- September 2, 1982
- Decision date
- September 17, 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 |
| K823165 | Wrist Spling & Forearm SplintILH · Traditional | Warm & Form, Orthopedic Materials | 11/16/1982SE |
| 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 |
|---|---|---|
| K963527 | Universal Econo-Strap, Qualcraft Universal StrapsFMQ · Traditional | 10/31/1996SE |
| K963528 | Alimed Positioning 7 Safety Straps (Three Types), Universal Cr/Mri Wide Body Strap…FMQ · Traditional | 10/29/1996SE |
| K963526 | Strap WedgeFMQ · Traditional | 10/28/1996SE |
| K920487 | Mini VibratorIRO · Traditional | 02/18/1992SE |
| K840156 | Protecta Coat SpongesIZZ · Traditional | 03/23/1984SE |
| K822650 | Super DonutKME · Traditional | 09/30/1982SE |
| K820516 | Arterial Canalization DeviceDQY · Traditional | 04/15/1982SE |
| K820517 | Constructa Foam · Traditional | 03/10/1982SE |
| K801743 | Plastazote ShoeKNP · Traditional | 08/07/1980SE |
| K791189 | Echo Cardiogram PadFNJ · Traditional | 07/17/1979SE |
Questions and answers
When was Total Finger Flexion Splint cleared by the FDA?
Total Finger Flexion Splint (K822651) received a 510(k) decision of Substantially Equivalent on September 17, 1982, 15 days after the submission was received.
What is the product code of K822651?
The FDA product code is ILH – Splint, Hand, And Components, a Class I (low risk) device regulated under 21 CFR 890.3475.