Velcro Splint Strap Fasteners
FDA 510(k) K812655 · Maddak, Inc.
510(k) numberK812655
Submission
- Device name
- Velcro Splint Strap Fasteners
- Applicant
- Maddak, Inc.
Mchenry, IL, US - Received
- September 17, 1981
- Decision date
- September 25, 1981
- 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 |
| K822651 | Total Finger Flexion SplintILH · Traditional | Alimed, Inc. | 09/17/1982SE |
| K821637 | Wire-Foam MP Flexion SpringILH · Traditional | Fred Sammons, Inc. | 06/11/1982SE |
More from Fred Sammons, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K841700 | Walk & RollINM · Traditional | 05/11/1984SE |
| K841698 | Heat PackIMA · Traditional | 05/10/1984SE |
| K841695 | CrawlerKNL · Traditional | 05/10/1984SE |
| K841697 | Hydro-Thero PadIRT · Traditional | 05/09/1984SE |
| K841693 | Standing Frame · Traditional | 05/09/1984SE |
| K841692 | Prone Stander · Traditional | 05/09/1984SE |
| K841691 | Split Seat Positioning ChairINN · Traditional | 05/09/1984SE |
| K834311 | Night TrainerKPN · Traditional | 03/30/1984SE |
| K833870 | Knee WalkerION · Traditional | 11/29/1983SE |
| K833177 | Glossectomy Feeding SpoonsILC · Traditional | 10/31/1983SE |
Questions and answers
When was Velcro Splint Strap Fasteners cleared by the FDA?
Velcro Splint Strap Fasteners (K812655) received a 510(k) decision of Substantially Equivalent on September 25, 1981, 8 days after the submission was received.
What is the product code of K812655?
The FDA product code is ILH – Splint, Hand, And Components, a Class I (low risk) device regulated under 21 CFR 890.3475.