Data / Medical devices / Unit, Heating, Powered
Unit, Heating, Powered (IRQ): 43 FDA-registered makers in 11 countries
43 establishments in 11 countries are registered with the FDA to make Unit, Heating, Powered (product code IRQ, Class 1, 21 CFR 890.5950). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on September 14, 2005, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- IRQ
- Device class
- 1
- Regulation
- 890.5950
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| China | 17 |
| United States | 9 |
| South Korea | 4 |
| Germany | 3 |
| Mexico | 3 |
| Hong Kong | 2 |
| Canada | 1 |
| Finland | 1 |
| Brazil | 1 |
| United Kingdom | 1 |
| Taiwan | 1 |
Makers of Unit, Heating, 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 |
|---|---|---|---|---|---|---|---|---|
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet Microfixation | Jacksonville, FL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Compass Health Brands (corporate Office) | Middleburg Heights, OH, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Core Products International Inc | Chetek, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Disk DR. Co., Ltd. | Hanam-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DJ Orthopedics De Mexico, S.A. De C.V. | TIJUANA Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Djo, LLC | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Quanding Medical Supplies Co., Ltd | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Tutamen Metalwork Co.,LTD. | Dongguan Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Equipro Equipements D'Esthetique Inc. | Montreal Quebec, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Grahope New Materials Technologies Inc. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hanil Medical Co., Ltd. | Gwangju-si, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HEALING T.F.K Co., Ltd. | Chilgok-gun Gyeongbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Health Body World Supply, Inc. Dba The Wabbo Company | Lake Elsinore, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Mita Biotechnology Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hefei Morningstar Healthmate Fitness Co.,ltd | Hefei Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inion OY | TAMPERE Pirkanmaa, Finland | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ibramed Industria Brasileira de Equipamentos Medicos Ltda | Amparo Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Moen Industrial Co.,ltd | Suqian Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karis Co., Ltd. | Gimpo-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KLS Martin SE & Co. KG | Muhlheim/Donau Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KLS-Martin L.P. | Jacksonville, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linjiang (holdings) Limited | Shangqiu Henan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marturion Electronics Ltd | Lisburn Northern Ireland, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mibo Medical Group | Irving, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oman Medical Beauty Manufacture Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onlycare Inc | Denver, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Picard Healthcare Technology (Dongguan) Co. Ltd | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Eyco Technology Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Joose Beauty Electronic Co.,ltd | Shen Zhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Obestec Industrial Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Shengbanghua Technology Development Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Youmay Electronics Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Leibinger GMBH & Co. KG | FREIBURG Baden-Wurttemberg, Germany | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Jeno Dream Home Technology Co., Ltd | Changshu Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tutamen De Mexico, LLC | Tijuana Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tianjin Zhengtian Medical Instrument Co., Ltd. | Tianjin, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VADI Medical Technology Co., Ltd. | Taoyuan City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan Kingdom Electrical Appliance Co., Ltd. | Zhongshan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan Todom Electrical Appliance Co., Ltd | Zhongshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan Bisen Plastic Electronic Products Co.,Ltd | Zhongshan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 14, 2005. 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.