Data / Medical devices / System, Environmental Control, Powered
System, Environmental Control, Powered (IQA): 15 FDA-registered makers in 10 countries
15 establishments in 10 countries are registered with the FDA to make System, Environmental Control, Powered (product code IQA, Class 2, 21 CFR 890.3725). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 24 510(k) clearances under this code, the latest on June 27, 1996, and lists 13 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- IQA
- Device class
- 2
- Regulation
- 890.3725
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Japan | 1 |
| Sweden | 1 |
| Israel | 1 |
| Vietnam | 1 |
| Taiwan | 1 |
| India | 1 |
| Mexico | 1 |
| Thailand | 1 |
| China | 1 |
Makers of System, Environmental Control, Powered
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Accessibility Services, Inc. | Homosassa, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AIPHONE CO., LTD., Toyota Factory | Toyota Aichi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ascom Sweden AB | Goteborg Vastra Gotaland, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AeroScout, Ltd. | Ness Ziona Central, Israel | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Auspic Electronic | Binh Duong Ward, Ho Chi Minh City, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chowsons International Inc | Tainan City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Control Bionics Inc. | Milford, OH, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Crest Electronics Inc. | Dassel, MN, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Curbell Medical Products, Inc. | Orchard Park, NY, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cyient DLM Limited | HYDERABAD Telangana, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GPV Americas Mexico | Zapopan Jalisco, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GPV Asia (thailand) Co.,ltd. | Muang Samutprakarn Samut Prakan, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Securitas Healthcare LLC | Lincoln, NE, United States | Manufacturer | 0 | 0 | 9 | 0 | api.fda.gov | |
| Tektone Sound & Signal Manufacturing, Inc. | Franklin, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yuiyn Hoo Industrial Limited | Dong Guan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 27, 1996. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.