Stimulator, Electro-Acupuncture
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Anhui and Jiangsu: 2 hold an FDA registration.
- Bozhou Rongjian Medical Appliance Co., Ltd. Anhui
- Wuxi Jiajian Medical Instrument Co., Ltd. Jiangsu, contract manufacturer
How Is BWK Classified?
Stimulator, Electro-Acupuncture is FDA product code BWK, unclassified.
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. Chinese applicants hold 5 clearances under this code; the FDA took a median of 149 days from receipt to decision on them.
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