Cervical Collar
FDA 510(k) K823667 · Warm & Form, Orthopedic Materials
510(k) numberK823667
Submission
- Device name
- Cervical Collar
- 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
- IQK – Orthosis, Cervical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3490
- Specialty
- Physical Medicine
Other 510(k)s with product code IQK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K930730 | Dormie Neck Support SystemIQK · Traditional | The Western Diagnostics Co. | 07/22/1993SE |
| K926291 | Schul-Tec ImmobilizerIQK · Traditional | Medical Emergency Support Equipment | 03/30/1993SE |
| K896042 | Medical Disposable BeddingIQK · Traditional | Keystone Veterinary Supplies, Inc. | 01/10/1990SE |
| K895477 | Nova PillowIQK · Traditional | Nova Health Systems, Inc. | 01/10/1990SE |
| K882264 | Battle Creek PillowIQK · Traditional | Battle Creek Equipment Co. | 08/09/1988SE |
| K850465 | Cervical Collars & Head HaltersIQK · Traditional | Abco Dealers, Inc. | 04/25/1985SE |
| K832990 | Stifnick Immobilizing CollarIQK · Traditional | Laerdal California, Inc. | 11/07/1983SE |
| K832001 | Head-ImmobilizerIQK · Traditional | Int'L Safety Corp. | 07/12/1983SE |
| K831582 | Vari-Support Neck Posture PillowIQK · Traditional | Body Therapeutics, Inc. | 06/15/1983SE |
| K830351 | Disposable Extrication CollarIQK · Traditional | Deip Enterprises, Inc. | 03/09/1983SE |
More from Deip Enterprises, 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 |
| 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 |
| K823661 | Clavicle SupportIQJ · Traditional | 12/30/1982SE |
Questions and answers
When was Cervical Collar cleared by the FDA?
Cervical Collar (K823667) 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 K823667?
The FDA product code is IQK – Orthosis, Cervical, a Class I (low risk) device regulated under 21 CFR 890.3490.