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U.S. Department of Health and Human Services

510(k) Premarket Notification

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61 to 70 of 251 Results
ProductCode: ngx Decision Date To: 12/04/2016
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ems foot stimulator (model: hk701, hk701a, hk701b, hk701c) Guangzhou Hua Kai Electronic Technology Co., Ltd. K221251 07/29/2022
ems neck massager Xiamen Comfier Technology Co., Ltd K233492 12/20/2023
ems/tens massager device Shenzhen IMDK Medical Technology Co., Ltd. K233040 02/12/2024
enso (model 2) Hinge Health, Inc. K233784 02/23/2024
everyway otc ems, model ev-805 EVERYWAY MEDICAL INSTRUMENT CO., LTD. K162744 08/03/2017
everyway otc tens/ems combination EVERYWAY MEDICAL INSTRUMENTS CO., LTD. K192589 12/19/2019
everyway wireless tens & ems unit Everyway Medical Instruments Co., Ltd. K181707 09/26/2018
fastfit ems system Fast Fit LLC K192161 01/22/2020
fdes106 mini tens&ems device,fdes106 multi-function mini tens&ems device,fdes105 pain relief plaster,fdes107 abdominal FAMIDOC TECHNOLOGY CO., LTD K130723 02/07/2014
firefly FIRSTKIND LIMITED K134001 05/15/2014
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