FDA product code IQK: Orthosis, Cervical
IQK is the FDA product code for orthosis, cervical. It is a Class I device, regulated under 21 CFR 890.3490 and reviewed by the Physical Medicine panel. FDA has cleared 27 510(k) submissions under IQK, from 22 different applicants. The average 510(k) review took 50 days (median 29). FDA has posted 6 recalls for IQK devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Orthosis, Cervical |
| Device class | Class I |
| Regulation | 21 CFR 890.3490 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IQK clearance
Top IQK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Body Therapeutics, Inc. | 3 | 1983-06-15 |
| Deip Enterprises, Inc. | 3 | 1983-03-09 |
| Warm & Form, Orthopedic Materials | 2 | 1982-12-30 |
| The Western Diagnostics Co. | 1 | 1993-07-22 |
| Medical Emergency Support Equipment | 1 | 1993-03-30 |
17 more applicants have IQK clearances. See the full list in Caduvo.
Most recent IQK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K930730 | The Western Diagnostics Co. | DORMIE NECK SUPPORT SYSTEM | 1993-07-22 | 161 |
| K926291 | Medical Emergency Support Equipment | SCHUL-TEC IMMOBILIZER | 1993-03-30 | 106 |
| K895477 | Nova Health Systems, Inc. | NOVA PILLOW | 1990-01-10 | 121 |
| K896042 | Keystone Veterinary Supplies, Inc. | MEDICAL DISPOSABLE BEDDING | 1990-01-10 | 86 |
| K882264 | Battle Creek Equipment Co. | BATTLE CREEK PILLOW | 1988-08-09 | 70 |
Recalls for IQK devices
6 product recalls in 4 recall events; 2 initiated in the last five years and 1 still open. Most recent: 2024-08-20.
| Year | Recalls |
|---|---|
| 2021 | 2 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code IQK?
IQK is the FDA product code for orthosis, cervical. It is a Class I device, regulated under 21 CFR 890.3490 and reviewed by the Physical Medicine panel.
What device class is IQK?
Class I, regulation 21 CFR 890.3490. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IQK?
Across 27 cleared submissions the average was 50 days from receipt to decision (median 29).
Which companies have the most IQK clearances?
Body Therapeutics, Inc. (3); Deip Enterprises, Inc. (3); Warm & Form, Orthopedic Materials (2); The Western Diagnostics Co. (1); Medical Emergency Support Equipment (1).
Have IQK devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2024-08-20.
Next steps
- Run an FDA pathway report with predicate devices for product code IQK
- Run a recall and safety report across every IQK manufacturer
- Watch product code IQK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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