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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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trusculpt flex Johari Digital Healthcare Limited K212866 12/03/2022
corelevee Lutronic Corporation K213748 10/14/2022
miha bodytec ii Miha Bodytec GmbH K221498 10/07/2022
wireless tens/ems, bruno, aela ZMI Elecronics Ltd. K220997 09/01/2022
wiemspro Medical Cables S.L. K211298 08/25/2022
transcutaneous electrical nerve stimulator, model: ktr-405 Shenzhen Kentro Medical Electronics Co., Ltd. K220998 08/24/2022
ems foot stimulator (model: hk701, hk701a, hk701b, hk701c) Guangzhou Hua Kai Electronic Technology Co., Ltd. K221251 07/29/2022
heating tens/ems device, ft-240-1, heating tens/ems device, ft-240-2 Hivox Biotek Inc. K221384 06/11/2022
i-motion I-Motion Group Global Iberica S.L. K212413 05/26/2022
tens&ems stimulator (model: kres100d, kres1010, kres1020, kres1080) Dongguan Bohuikang Technology Co.,Ltd K213788 05/06/2022