FDA product code IQI: Orthosis, Limb Brace
IQI is the FDA product code for orthosis, limb brace. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel. FDA has cleared 52 510(k) submissions under IQI, from 34 different applicants. The average 510(k) review took 32 days (median 17). FDA has posted 17 recalls for IQI devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Orthosis, Limb Brace |
| Device class | Class I |
| Regulation | 21 CFR 890.3475 |
| 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 IQI clearance
Top IQI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fred Sammons, Inc. | 7 | 1983-06-24 |
| Orthomedics | 5 | 1981-06-12 |
| Conphar, Inc. | 4 | 1979-07-24 |
| Hosmer Dorrance Corp. | 3 | 1982-06-24 |
| Arco Matic, Inc. | 2 | 1982-11-16 |
29 more applicants have IQI clearances. See the full list in Caduvo.
Most recent IQI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K143458 | Neurospectrum, LLC | Neurosplint | 2015-08-13 | 252 |
| K052771 | Otto Bock Healthcare LP | SENSOR WALK | 2006-05-03 | 215 |
| K031576 | Surgitech, Inc. | SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 | 2003-07-31 | 72 |
| K926391 | Regulatory & Marketing Services, Inc. | ACCUFLEX DYNAMIC ELBOW ORTHOSIS | 1993-07-22 | 213 |
| K910974 | Mcconnell Orthopedic | MCCONNELL SHOULDER BRACE | 1991-03-21 | 14 |
Recalls for IQI devices
17 product recalls in 6 recall events; 3 initiated in the last five years and 0 still open. Most recent: 2023-09-23.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2023 | 3 |
Frequently asked questions
What is FDA product code IQI?
IQI is the FDA product code for orthosis, limb brace. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel.
What device class is IQI?
Class I, regulation 21 CFR 890.3475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IQI?
Across 52 cleared submissions the average was 32 days from receipt to decision (median 17).
Which companies have the most IQI clearances?
Fred Sammons, Inc. (7); Orthomedics (5); Conphar, Inc. (4); Hosmer Dorrance Corp. (3); Arco Matic, Inc. (2).
Have IQI devices been recalled?
Yes: 17 product recalls across 6 recall events; the most recent began 2023-09-23.
Next steps
- Run an FDA pathway report with predicate devices for product code IQI
- Run a recall and safety report across every IQI manufacturer
- Watch product code IQI 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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