The following data is part of a premarket notification filed by Shenzhen Kentro Medical Electronics Co., Ltd with the FDA for Low-frequency Multi-function Physiotherapy Instrument.
|Device Name:||Low-frequency Multi-function Physiotherapy Instrument|
|Classification||Stimulator, Nerve, Transcutaneous, Over-the-counter|
|Applicant||Shenzhen Kentro Medical Electronics Co., Ltd No.3, Xihu Industry Zone, Xikeng Village, Henggang Town Longgang District,shenzhen City, CN 518115|
Guangzhou GLOMED Biological Technology Co., Ltd. Room 2231, Building 1, Ruifeng Center, Kaichuang Road, Huangpu District Guangzhou, CN 51006
|CFR Regulation Number||882.5890 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|