Flexitouch
8 catalogue numbers from A-CH-SM-A, listed by Tactile Systems Technology Inc, United States, under Sleeve, Head And Neck, Compressible. 1 manufacturer in China is registered for this product code.
Sleeve, Head and Neck, Compressible
Which Manufacturers in China Make This?
The one Chinese manufacturer registered for this device type is based in Zhejiang.
- Jiaxing Max Hosiery Co., Ltd. Zhejiang
What Is This Device?
Intended to move excess fluid from the target area to another area of the body.
How Is PPS Classified?
Sleeve, Head And Neck, Compressible is FDA product code PPS, Class 2, 21 CFR 870.5800.
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.