IQKClass I
Orthosis, Cervical
21 CFR 890.3490 / Physical Medicine
IQK is the FDA product code for Orthosis, Cervical, a class I device type, regulated under 21 CFR 890.3490. As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and 6 recalls.
Classification record
- Product code
- IQK
- Device name
- Orthosis, Cervical
- Regulation
- 21 CFR 890.3490
- Device class
- Class I
- Review panel
- Physical Medicine
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- Yes
- Third party review eligible
- No
- Ingested clearances
- 27
- Ingested recalls
- 6
Clearances, product code IQK
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 2 |
| 1980 | 3 |
| 1981 | 4 |
| 1982 | 5 |
| 1983 | 6 |
| 1985 | 1 |
| 1988 | 1 |
| 1990 | 2 |
| 1993 | 2 |
Applicants with the most clearances
Product code IQK| Applicant | Clearances |
|---|---|
| Body Therapeutics, Inc. | 3 |
| Deip Enterprises, Inc. | 3 |
| Warm & Form, Orthopedic Materials | 2 |
| Abco Dealers, Inc. | 1 |
| Bashaw Custom Specialties, Inc. | 1 |
| Battle Creek Equipment | 1 |
| Bee Ent. | 1 |
| Blackstone & Breglio Industries | 1 |
| Conphar, Inc. | 1 |
| Ems Industries, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
