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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 20 of 206 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
well-life tens/ems/heating stimulator Well-Life Healthcare Limited K213091 02/19/2022
tens & pms (model: sm9126) Hong Qiangxing (Shen Zhen) Electronics Limited K220150 02/17/2022
venus blissmax Venus Concept USA Inc. K213308 01/12/2022
intrelief EasyMed Instruments Co., Ltd. K211263 12/30/2021
electrical neuromuscular stimulator (cure trio mc-310 ios, cure trio mc-310 android) Oriental Inspiration Limited K212285 12/22/2021
revitive medic coach (model number 5575aq) Actegy, Ltd. K210825 12/17/2021
heat stimplus Famidoc Technology Co., Ltd. K212918 12/13/2021
heating lumbar therapy cushion (model: ast-622, ast-622b, ast-623, ast-623b) Shenzhen OSTO Technology Company Limited K211942 12/13/2021
low-frequency stimulator (model: ast-645, ast-646) Shenzhen OSTO Technology Co., Ltd. K212989 11/22/2021