Implantable Cardioverter Defibrillator (Non-Crt)
Which Manufacturers in China Make This?
One manufacturer in China holds an FDA registration for this device type, based in Guangdong. All of them are contract manufacturers, able to build to a buyer’s own specification.
- Amphenol Medical Technologies (Dongguan) Co., Ltd. Guangdong, contract manufacturer
What Is It?
These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.
How Is LWS Classified?
Implantable Cardioverter Defibrillator (Non-Crt) is FDA product code LWS, Class 3.
How Does It Reach the US Market?
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 Has Gone Wrong With It?
The FDA has recorded 219 recalls under this product code since 2003. None was by a company in China. 81 are Class I, the most serious grade.
The root causes the FDA records most often are Device Design (30), Software design (27) and Nonconforming Material/Component (24). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.