Stimulator, Spinal-Cord, Totally Implanted for Pain Relief
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Jiangsu and Shanghai: 2 hold an FDA registration. 2 are contract manufacturers.
- Jiangyin Sinbon Electronics Co Ltd Jiangsu, contract manufacturer
- Jabil Circuit (Shanghai) Ltd. Shanghai, contract manufacturer
How Is LGW Classified?
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief is FDA product code LGW, 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 96 recalls under this product code since 2004. None was by a company in China. 8 are Class I, the most serious grade.
The root causes the FDA records most often are Device Design (11), Vendor change control (11) and Software design (10). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.