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U.S. Department of Health and Human Services

510(k) Premarket Notification

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31 to 40 of 207 Results
ProductCode: ngx Decision Date To: 05/21/2022
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cur model 1 Thimble Bioelectronics, Inc. K160052 05/20/2016
dr-ho's back pain relief system pro (models bprs-i and bprs-ii) Guangzhou Xinbo Electronic Co., Ltd. K202671 11/12/2021
dr.music 3s SmartMedicalDevice Co., Ltd. K172451 11/17/2017
dual output digital therapy massager Shenzhen OSTO Technology Co., Ltd. K172834 09/06/2018
e-fit ef-1280 ems machine FIT-PRO KFT LTD. K133225 10/24/2014
e-fit infinity system (ef-2090 controller and ef-100 unit) Fit-Pro Ltd. K202148 08/25/2021
electrical neuromuscular stimulator (cure trio mc-310 ios, cure trio mc-310 android) Oriental Inspiration Limited K212285 12/22/2021
electrical stimulator - model r-c1 tens and ems stimulator, model r-e1 ems stimulator, model r-t1 tens stimulator Shenzhen Roundwhale Technology Co., Ltd. K180956 06/07/2018
electrical stimulator system Gymmax Technology Shenzen Co., Ltd. K192201 06/12/2020
electronic muscle stimulator (model: ast-300a, ast-300n, ast-300s, ast-300t, ast-300v, ast-300w) Shenzhen OSTO Technology Company Limited K211736 09/05/2021