Limb Holder Arm Sling
FDA 510(k) K812480 · Maddak, Inc.
510(k) numberK812480
Submission
- Device name
- Limb Holder Arm Sling
- Applicant
- Maddak, Inc.
Mchenry, IL, US - Received
- August 31, 1981
- Decision date
- September 14, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ILI – Sling, Arm
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3640
- Specialty
- Physical Medicine
Other 510(k)s with product code ILI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K912661 | Matrx, Pyramid Triangle BandageILI · Traditional | Matrix Medica, Inc. | 08/21/1991SE |
| K831549 | Arm SlingsILI · Traditional | Fred Sammons, Inc. | 06/30/1983SE |
| K831706 | Sato Family First Aid KitILI · Traditional | Food and Drug Service, Inc. | 06/24/1983SE |
| K823810 | A.C. SplintILI · Traditional | Danek Medical, Inc. | 01/14/1983SE |
| K823808 | Various Arm SlingILI · Traditional | Danek Medical, Inc. | 01/14/1983SE |
| K823664 | Universal Sling, Sling & SwatheILI · Traditional | Warm & Form, Orthopedic Materials | 12/30/1982SE |
| K823162 | Universal Sling, Sling & SwatheILI · Traditional | Warm & Form, Orthopedic Materials | 11/10/1982SE |
| K820590 | Orthopedic Soft GoodsILI · Traditional | Abco Dealers, Inc. | 03/26/1982SE |
| K812478 | Maddacomfort SlingILI · Traditional | Maddak, Inc. | 09/14/1981SE |
| K812477 | Arm Sling, Pouch TypeILI · Traditional | Maddak, Inc. | 09/14/1981SE |
More from Maddak, 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 Limb Holder Arm Sling cleared by the FDA?
Limb Holder Arm Sling (K812480) received a 510(k) decision of Substantially Equivalent on September 14, 1981, 14 days after the submission was received.
What is the product code of K812480?
The FDA product code is ILI – Sling, Arm, a Class I (low risk) device regulated under 21 CFR 890.3640.