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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 204 Results
ProductCode: ngx Decision Date To: 05/21/2022
 
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tens&ems stimulator (model: kres100d, kres1010, kres1020, kres1080) Dongguan Bohuikang Technology Co.,Ltd K213788 05/06/2022
tens & pms (model:sm9009, sm9021, sm9128h, sm9015, sm9055, sm9033) Hong Qiangxing (Shen Zhen) Electronics Limited K220283 05/02/2022
venus blissmax Venus Concept USA Inc. K220592 04/27/2022
tens & pms (model:sm9089, sm9587, sm9592, sm9555) Hong Qiangxing (Shen Zhen) Electronics Limited K220152 04/19/2022
cooltone Zimmer MedizinSysteme GmbH K220601 04/01/2022
tens & pms unit Shenzhen Yuehua Xinsen Technology Co., Ltd. K220005 04/01/2022
tens and ems stimulation (otc) Changsha Yuwen Medical Equipment Co.,Ltd. K212184 04/01/2022
tens & ems device (model: fm-b2403a) Shenzhen Jianfeng Electronic Technology Co. Ltd. K213741 03/08/2022
tens & ems device Shenzhen Jian feng Electronic Technology Co. Ltd. K213835 03/03/2022
well-life tens/ems/heating stimulator Well-Life Healthcare Limited K213091 02/19/2022
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