System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Guangdong: 2 hold an FDA registration. 2 are contract manufacturers.
- Amphenol Alden Products Company Guangdong, contract manufacturer
- MediConcepts Technology (Shenzhen) Company Limited Guangdong, contract manufacturer
How Is MEQ Classified?
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy is FDA product code MEQ, Class 3.
What Does It Take to Sell It in the United States?
A premarket approval is required: the Class 3 route, granted on clinical evidence rather than on equivalence to an existing device. No approval under this code names a Chinese applicant.
What Do the Recalls Say?
The FDA has recorded 9 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (1), Incorrect or no expiration date (1) and Process design (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.