FDA product code IQE: Orthosis, Lumbar
IQE is the FDA product code for orthosis, lumbar. It is a Class I device, regulated under 21 CFR 890.3490 and reviewed by the Physical Medicine panel. FDA has cleared 4 510(k) submissions under IQE, from 4 different applicants. The average 510(k) review took 15 days (median 14).
Classification
| Field | Value |
|---|---|
| Device name | Orthosis, Lumbar |
| 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 IQE clearance
Top IQE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Surgical Appliance Industries, Inc. | 1 | 1982-06-24 |
| Obus Forme, Ltd. | 1 | 1982-01-29 |
| Bandwagon, Inc. | 1 | 1981-10-06 |
| Fred Sammons, Inc. | 1 | 1981-03-04 |
Most recent IQE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K821682 | Surgical Appliance Industries, Inc. | TRUNCAL ORTHOSIS | 1982-06-24 | 16 |
| K820051 | Obus Forme, Ltd. | OBUS FORME ORTHOPEDIC BRACE, UPRIGHT | 1982-01-29 | 21 |
| K812719 | Bandwagon, Inc. | PROSANA BELT | 1981-10-06 | 11 |
| K810450 | Fred Sammons, Inc. | TRUNCAL ORTHOSIS | 1981-03-04 | 13 |
Recalls for IQE devices
openFDA lists no recalls for product code IQE.
Frequently asked questions
What is FDA product code IQE?
IQE is the FDA product code for orthosis, lumbar. It is a Class I device, regulated under 21 CFR 890.3490 and reviewed by the Physical Medicine panel.
What device class is IQE?
Class I, regulation 21 CFR 890.3490. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IQE?
Across 4 cleared submissions the average was 15 days from receipt to decision (median 14).
Which companies have the most IQE clearances?
Surgical Appliance Industries, Inc. (1); Obus Forme, Ltd. (1); Bandwagon, Inc. (1); Fred Sammons, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IQE
- Run a recall and safety report across every IQE manufacturer
- Watch product code IQE 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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