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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 20 of 251 Results
ProductCode: ngx Decision Date To: 10/01/2016
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tens and ems stimulation (otc) Changsha Yuwen Medical Equipment Co., Ltd K230163 03/20/2023
body contouring machine (models: cs2, cs3, cs5, cs7, cs8, cs11, cs13) Hebei JT Medical Co., Ltd. K232181 04/24/2024
electromagnetic stimulator device(model em contouring and tesla duet) Beijing ADSS Development Co., Ltd. K231318 07/07/2023
enso (model 2) Hinge Health, Inc. K233784 02/23/2024
manaflexx 2 (model: mf002-rx, mf002-otc) ManaMed, Inc K231569 11/03/2023
muscle stimulator Shenzhen Yiran Intelligent Co., Ltd K231648 03/01/2024
tens and ems stimulation (otc) Changsha Yuwen Medical Equipment Co., Ltd K230164 04/10/2023
hi-dow pro touch wireless 6-12 (hd-19a) Hi-Dow International, Inc. K233461 01/19/2024
pain therapy device (model: p.t.s-vi, p.t.s-vii) Guangzhou Xinbo Electronic Co., Ltd. K231789 03/11/2024
tens & ems device (ly-et-01, ly-et-02, ly-et-04) Jiangxi Royall Smart Technology Co., Ltd. K230443 05/22/2023
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