Cervical Pillow
FDA 510(k) K830350 · Deip Enterprises, Inc.
510(k) numberK830350
Submission
- Device name
- Cervical Pillow
- Applicant
- Deip Enterprises, Inc.
Mchenry, IL, US - Received
- February 3, 1983
- Decision date
- March 9, 1983
- 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.
Questions and answers
When was Cervical Pillow cleared by the FDA?
Cervical Pillow (K830350) received a 510(k) decision of Substantially Equivalent on March 9, 1983, 34 days after the submission was received.
What is the product code of K830350?
The FDA product code is IQK – Orthosis, Cervical, a Class I (low risk) device regulated under 21 CFR 890.3490.