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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 213 Results
ProductCode: ngx Decision Date To: 05/21/2022
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xiniwave ii model ecs322p International Trade Group, Inc. K171092 07/10/2017
xbody newave usa XBody Hungary Kft. K190038 04/05/2019
x2abs dual channel fitness belt LETO ENTERPRISES INCORPORATION K102295 02/18/2011
wireless tens/ems, bruno, aela ZMI Elecronics Ltd. K220997 09/01/2022
wireless pain relieve device model: lt5018c Shenzhen Dongdixin Technology Co.,Ltd. K173462 12/08/2017
wiemspro Medical Cables S.L. K211298 08/25/2022
wiemspro Medical Cables, S.L. K181955 02/12/2019
well-life tens/ems/heating stimulator Well-Life Healthcare Limited K213091 02/19/2022
well-life otc ems system WELL-LIFE HEALTHCARE LIMITED K102786 07/01/2011
well life wireless tens/ems stimulator, models wr-2605/2605a WELL-LIFE HEALTHCARE LIMITED K161453 12/05/2016