FDA product code IQA: System, Environmental Control, Powered
IQA is the FDA product code for system, environmental control, powered. It is a Class II device, regulated under 21 CFR 890.3725 and reviewed by the Physical Medicine panel. FDA has cleared 24 510(k) submissions under IQA, from 17 different applicants. The average 510(k) review took 74 days (median 59). FDA has posted 17 recalls for IQA devices, 11 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Environmental Control, Powered |
| Device class | Class II |
| Regulation | 21 CFR 890.3725 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IQA clearance
Top IQA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Prentke Romich Co. | 3 | 1996-06-27 |
| Rehab Technology, Inc. | 3 | 1985-04-25 |
| Apt Technology, Inc. | 2 | 1995-10-31 |
| Baylor Biomedical Services | 2 | 1990-03-13 |
| J. H. Emerson Co. | 2 | 1987-09-24 |
12 more applicants have IQA clearances. See the full list in Caduvo.
Most recent IQA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K961306 | Prentke Romich Co. | DELTATALKER WITH INFRARED | 1996-06-27 | 84 |
| K953905 | Teledyne Brown Engineering | IMPERIUM | 1995-11-21 | 95 |
| K953937 | Apt Technology, Inc. | LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEM | 1995-10-31 | 74 |
| K943244 | Apt Technology, Inc. | DEUCE | 1995-09-11 | 432 |
| K944585 | Prentke Romich Co. | SCANNING DIRECTOR | 1995-02-21 | 155 |
Recalls for IQA devices
17 product recalls in 13 recall events; 11 initiated in the last five years and 12 still open. Most recent: 2025-12-08.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2023 | 4 |
| 2024 | 4 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code IQA?
IQA is the FDA product code for system, environmental control, powered. It is a Class II device, regulated under 21 CFR 890.3725 and reviewed by the Physical Medicine panel.
What device class is IQA?
Class II, regulation 21 CFR 890.3725. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IQA?
Across 24 cleared submissions the average was 74 days from receipt to decision (median 59).
Which companies have the most IQA clearances?
Prentke Romich Co. (3); Rehab Technology, Inc. (3); Apt Technology, Inc. (2); Baylor Biomedical Services (2); J. H. Emerson Co. (2).
Have IQA devices been recalled?
Yes: 17 product recalls across 13 recall events; the most recent began 2025-12-08.
Next steps
- Run an FDA pathway report with predicate devices for product code IQA
- Run a recall and safety report across every IQA manufacturer
- Watch product code IQA 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.
All Physical Medicine product codes · FDA product code lookup · 510(k) database search · 510(k) review times