Orthopedic Soft Goods
FDA 510(k) K820590 · Abco Dealers, Inc.
510(k) numberK820590
Submission
- Device name
- Orthopedic Soft Goods
- Applicant
- Abco Dealers, Inc.
Mchenry, IL, US - Received
- March 4, 1982
- Decision date
- March 26, 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 |
| 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 |
| 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 |
|---|---|---|
| K905025 | Digital Thermometer KitsFLL · Traditional | 02/07/1991SE |
| K882304 | Digital Thermometer Sheaths (Oral and Rectal)FLL · Traditional | 07/12/1988SE |
| K880892 | Blood Collecting Needle and HoldersFMI · Traditional | 04/21/1988SE |
| K880894 | Allergist SyringesFMF · Traditional | 03/31/1988SE |
| K872875 | Stretch Gauze BandagesNAD · Traditional | 09/04/1987SE |
| K872874 | Microscope Cover GlassesKES · Traditional | 08/10/1987SE |
| K872797 | Non-Skid Shoe CoversFXP · Traditional | 08/04/1987SE |
| K871465 | Thermometer SheathsFLL · Traditional | 05/11/1987SE |
| K862726 | Disposable Shoe Covers and Nurses CapsFXP · Traditional | 08/01/1986SE |
| K862111 | Armboards, Reusable and Disposable · Traditional | 07/08/1986SE |
Questions and answers
When was Orthopedic Soft Goods cleared by the FDA?
Orthopedic Soft Goods (K820590) received a 510(k) decision of Substantially Equivalent on March 26, 1982, 22 days after the submission was received.
What is the product code of K820590?
The FDA product code is ILI – Sling, Arm, a Class I (low risk) device regulated under 21 CFR 890.3640.