Stimulator, Electrical, Implanted, for Parkinsonian Symptoms
Which Manufacturers in China Make This?
One manufacturer in China holds an FDA registration for this device type, based in Shanghai.
- Jabil Circuit (Shanghai) Ltd. Shanghai, contract manufacturer
What Is It?
Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic Activa Parkinson’s Control Therapy is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinsons disease that are not adequately controlled with medication.
How Is NHL Classified?
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms is FDA product code NHL, 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 Do the Recalls Say?
The FDA has recorded 4 recalls under this product code since 2019. None was by a company in China. The root causes the FDA records most often are Component change control (1), Labeling Change Control (1) and Labeling design (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.