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 (model: Ktr-2230, Ktr-2220, Ktr-2210, Ktr-2231, Ktr-2221, Ktr-2211, Ktr-2232, Ktr-2222, Ktr-2212).
|Device Name:||Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)|
|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|