Deluxe Knee Immobilizer(Universal)
FDA 510(k) K823658 · Warm & Form, Orthopedic Materials
510(k) numberK823658
Submission
- Device name
- Deluxe Knee Immobilizer(Universal)
- 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
- ITQ – Joint, Knee, External Brace
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3475
- Specialty
- Physical Medicine
Other 510(k)s with product code ITQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K831044 | Limited Motion Functional Knee BraceITQ · Traditional | Orthopedic Systems, Inc. | 06/24/1983SE |
| K831310 | Brace C.T.ITQ · Traditional | Innovation Sports, Inc. | 05/16/1983SE |
| K823397 | Anatomic Fracture BraceITQ · Traditional | Orthopedic Systems, Inc. | 11/29/1982SE |
| K823159 | Deluxe Knee ImmobilizerITQ · Traditional | Warm & Form, Orthopedic Materials | 11/10/1982SE |
| K812423 | Neoprene Knee SupportITQ · Traditional | Surgical Appliance Industries, Inc. | 09/14/1981SE |
| K812094 | Aircast Pneumatic Knee BraceITQ · Traditional | Aircast, Inc. | 08/13/1981SE |
| K811689 | Cylinder Knee Cast/SplintITQ · Traditional | Surgical Appliance Industries, Inc. | 06/25/1981SE |
| K810222 | Limb OrhtosisITQ · Traditional | Medical Design & Manufacturing Corp. | 02/04/1981SE |
| K802673 | Knee Brace/StabilizerITQ · Traditional | Omni Scientific, Inc. | 11/12/1980SE |
| K780892 | Fracture BracingITQ · Traditional | Hosmer Dorrance Corp. | 06/13/1978SE |
More from Hosmer Dorrance Corp.
| 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 |
| K823664 | Universal Sling, Sling & SwatheILI · Traditional | 12/30/1982SE |
| K823663 | Abdominal BinderKTD · Traditional | 12/30/1982SE |
| K823662 | Rib Belt (Universal)IPX · Traditional | 12/30/1982SE |
Questions and answers
When was Deluxe Knee Immobilizer(Universal) cleared by the FDA?
Deluxe Knee Immobilizer(Universal) (K823658) 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 K823658?
The FDA product code is ITQ – Joint, Knee, External Brace, a Class I (low risk) device regulated under 21 CFR 890.3475.