Drill, Battery Powered, Subungual Hematoma
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Jiangsu.
- Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
What Is It?
Intended to cut a hole in finger and toe nails to release fluid accumulated in the underlying nail bed. Indicated to relieve pressure from subungual hematomas (including black toe).
How Is NWF Classified?
Drill, Battery Powered, Subungual Hematoma is FDA product code NWF, Class 1, 21 CFR 878.4820.
How Does It Reach the US Market?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
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