Circular Coil 90 Mm
Catalogue number B9621086002, listed by EB Neuro SPA, under Stimulator, Electrical, Evoked Response. 3 manufacturers in China are registered for this product code.
Stimulator, Electrical, Evoked Response
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are concentrated in Guangdong, Shaanxi and Shandong: 3 hold an FDA registration. 3 are contract manufacturers.
- Shandong Weigao Orthopaedic Device Co., Ltd. Shandong, contract manufacturer
- Shenzhen Launch Electrical Co., Ltd. Guangdong, contract manufacturer
- Xian Friendship Medical Electronics Co., Ltd. Shaanxi, contract manufacturer
How Is GWF Classified?
Stimulator, Electrical, Evoked Response is FDA product code GWF, Class 2, 21 CFR 882.1870.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. No clearance under this code names a Chinese applicant.
A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.
What Has Gone Wrong With It?
The FDA has recorded 16 recalls under this product code since 2006. None was by a company in China. 1 is Class I, the most serious grade.
The root causes the FDA records most often are Device Design (4), Software Design Change (3) and Software design (2). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
Name
Record
Butterfly Coil 70 Mm Air Cooled
Catalogue number B9621086004, listed by EB Neuro SPA, under Stimulator, Electrical, Evoked Response. 3 manufacturers in China are registered for this product code.