Universal Sling, Sling & Swathe
FDA 510(k) K823664 · Warm & Form, Orthopedic Materials
510(k) numberK823664
Submission
- Device name
- Universal Sling, Sling & Swathe
- Applicant
- Warm & Form, Orthopedic Materials
Walker, MI, US - Received
- December 6, 1982
- Decision date
- December 30, 1982
- 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 |
| 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 |
| K812477 | Arm Sling, Pouch TypeILI · Traditional | Maddak, Inc. | 09/14/1981SE |
More from Maddak, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K830245 | Head HalterILZ · Traditional | 03/09/1983SE |
| K830244 | Traction AccessoriesHST · Traditional | 03/09/1983SE |
| K830243 | Abduction PillowIOZ · Traditional | 03/08/1983SE |
| K830246 | Cast Shoe, Cast BootJQB · Traditional | 02/18/1983SE |
| K823667 | Cervical CollarIQK · Traditional | 12/30/1982SE |
| K823666 | Universal Wrist Splint & Forearm SplintILH · Traditional | 12/30/1982SE |
| K823665 | Rotation BootKNP · Traditional | 12/30/1982SE |
| K823663 | Abdominal BinderKTD · Traditional | 12/30/1982SE |
| K823662 | Rib Belt (Universal)IPX · Traditional | 12/30/1982SE |
| K823661 | Clavicle SupportIQJ · Traditional | 12/30/1982SE |
Questions and answers
When was Universal Sling, Sling & Swathe cleared by the FDA?
Universal Sling, Sling & Swathe (K823664) received a 510(k) decision of Substantially Equivalent on December 30, 1982, 24 days after the submission was received.
What is the product code of K823664?
The FDA product code is ILI – Sling, Arm, a Class I (low risk) device regulated under 21 CFR 890.3640.