Arm Sling
FDA 510(k) K801626 · The Owenby Co.
510(k) numberK801626
Submission
- Device name
- Arm Sling
- Applicant
- The Owenby Co.
Mchenry, IL, US - Received
- July 15, 1980
- Decision date
- July 28, 1980
- 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 |
| K812480 | Limb Holder Arm SlingILI · Traditional | Maddak, Inc. | 09/14/1981SE |
| K812478 | Maddacomfort SlingILI · Traditional | Maddak, Inc. | 09/14/1981SE |
More from Maddak, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K801628 | Restraint, ProtectiveIQK · Traditional | 08/07/1980SE |
| K801627 | Cover, LimbIPM · Traditional | 07/28/1980SE |
| K801532 | Stockinette, Sterile Two Ply W/Pull TabsFQM · Traditional | 07/28/1980SE |
| K801531 | Arm SlingILI · Traditional | 07/21/1980SE |
| K790210 | Stockinette, Tubular UnbleachedFQM · Traditional | 02/27/1979SE |
| K780764 | Non-Sterile Folded GauzeNAB · Traditional | 06/06/1978SE |
| K780418 | Burn Dressing PadFPY · Traditional | 04/10/1978SE |
| K770889 | Burn Dressing KitEFQ · Traditional | 07/11/1977SE |
| K761071 | P.S.M. Justa KapFYF · Traditional | 12/30/1976SE |
| K761070 | P.S.M. Surgical HoodFXY · Traditional | 12/30/1976SE |
Questions and answers
When was Arm Sling cleared by the FDA?
Arm Sling (K801626) received a 510(k) decision of Substantially Equivalent on July 28, 1980, 13 days after the submission was received.
What is the product code of K801626?
The FDA product code is ILI – Sling, Arm, a Class I (low risk) device regulated under 21 CFR 890.3640.