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U.S. Department of Health and Human Services

510(k) Premarket Notification

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21 to 30 of 213 Results
ProductCode: ngx Decision Date To: 05/21/2022
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tens & ems device Shenzhen Jian feng Electronic Technology Co. Ltd. K213835 03/03/2022
tens&ems stimulator (model: kres100d, kres1010, kres1020, kres1080) Dongguan Bohuikang Technology Co.,Ltd K213788 05/06/2022
trusculpt flex Johari Digital Healthcare Limited K212866 12/03/2022
wiemspro Medical Cables S.L. K211298 08/25/2022
bemer therapy systems, bemer classic set, bemer pro-set Bemer INT. AG K210174 02/04/2021
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
heat stimplus Famidoc Technology Co., Ltd. K212918 12/13/2021
pain therapy device(model: dh-p.t.s-i, dh-p.t.s-ii, dh-p.t.s-iia, dh-p.t.s-iib, dh-cp-i) Guangzhou Xinbo Electronic Co., Ltd. K212948 11/01/2021
revitive medic coach (model number 5575aq) Actegy, Ltd. K210825 12/17/2021
tens & ems device (model: fm-b2403a) Shenzhen Jianfeng Electronic Technology Co. Ltd. K213741 03/08/2022