Data / Medical devices / System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy (MEQ): 6 FDA-registered makers in 3 countries
6 establishments in 3 countries are registered with the FDA to make System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy (product code MEQ, Class 3). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 8 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MEQ
- Device class
- 3
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Mexico | 1 |
| China | 1 |
Makers of System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
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 |
|---|---|---|---|---|---|---|---|---|
| Medifocus Inc | Columbia, MD, United States | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Urologix, LLC | Plymouth, MN, United States | Manufacturer, Remanufacturer | 0 | 1 | 4 | 0 | api.fda.gov | |
| Amphenol Alden Products Company | Hermosillo Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MediConcepts Technology (Shenzhen) Company Limited | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spectrum Plastics Group | Saint Louis Park, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xeridiem Medical Devices | Tucson, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.