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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 20 of 212 Results
ProductCode: ngx Decision Date To: 05/21/2022
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wireless tens/ems, bruno, aela ZMI Elecronics Ltd. K220997 09/01/2022
tens and ems stimulation (otc) Changsha Yuwen Medical Equipment Co.,Ltd. K212184 04/01/2022
venus blissmax Venus Concept USA Inc. K213308 01/12/2022
well-life tens/ems/heating stimulator Well-Life Healthcare Limited K213091 02/19/2022
corelevee Lutronic Corporation K213748 10/14/2022
heating lumbar therapy cushion (model: ast-622, ast-622b, ast-623, ast-623b) Shenzhen OSTO Technology Company Limited K211942 12/13/2021
intrelief EasyMed Instruments Co., Ltd. K211263 12/30/2021
low-frequency stimulator (model: ast-645, ast-646) Shenzhen OSTO Technology Co., Ltd. K212989 11/22/2021
powerdot pd-01mt2 muscle stimulator Smartmissimo Technologies Pte Ltd K210269 02/23/2021
powerdot pd-01mt2 muscle stimulator Smartmissimo Technologies Pte Ltd K210938 07/30/2021
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