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U.S. Department of Health and Human Services

510(k) Premarket Notification

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21 to 30 of 249 Results
ProductCode: ngx Decision Date To: 05/25/2015
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nova hd+ Aura Wellness, LLC K220938 08/22/2023
nuera tight rf family BIOS s.r.l. K223856 08/11/2023
electromagnetic stimulator device(model em contouring and tesla duet) Beijing ADSS Development Co., Ltd. K231318 07/07/2023
fitness belt (model: klt-07) Shenzhen KeLuTongDa Industrial Co.,Ltd. K231136 06/16/2023
bemer therapy system evo Bemer INT AG K231368 06/09/2023
gnesis ems plus Creative Fitness Developments S.L. K230261 06/06/2023
tens & ems device (ly-et-01, ly-et-02, ly-et-04) Jiangxi Royall Smart Technology Co., Ltd. K230443 05/22/2023
transcutaneous electrical nerve stimulator, model: ktr-4031, ktr-4032, ktr-4012, ktr-4015, ktr-4029, ktr-4027, ktr-4026, ktr-4021, ktr-4034, ktr-4036, ktr-4037, ktr-4039 Shenzhen Kentro Medical Electronics Co., Ltd K222870 05/10/2023
tens & ems device Shenzhen Jian Feng Electronic Technology Co., Ltd K223825 05/09/2023
tens and ems stimulation (otc) Changsha Yuwen Medical Equipment Co., Ltd K230164 04/10/2023
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