Sunlamp Products (Pre-Standard)
Which Manufacturers in China Make This?
The one Chinese manufacturer registered for this device type is based in Shanghai. 1 is a contract manufacturer.
- Global Fabtech Wheel Chair (Shanghai) Co., Ltd. Shanghai, contract manufacturer
What Is It?
A sunlamp product assembled or manufactured before november 9, 1979. These are Class II medical devices as of 2014.
How Is RAB Classified?
Sunlamp Products (Pre-Standard) is FDA product code RAB, Class 2, 21 CFR 878.4635.
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. It is exempt from most of the quality system regulation.
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.