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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 145 Results
ProductCode: ngx Decision Date To: 02/24/2020
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katalyst training system Katalyst Inc. K190966 02/03/2020
fastfit ems system Fast Fit LLC K192161 01/22/2020
everyway otc tens/ems combination EVERYWAY MEDICAL INSTRUMENTS CO., LTD. K192589 12/19/2019
health expert electronic stimulator Shenzhen OSTO Technology Company Limited K190673 12/12/2019
sunmas tens & pms (model sm9187, sm9180l, sm9180s) Hong Qiangxing (Shen Zhen) Electronics Limited K190009 12/02/2019
cooltone Zimmer MedizinSysteme GmbH K192940 11/15/2019
hivox spopad ems sp-911, sp-921 Hivox Biotek Inc. K192264 11/08/2019
combo electrotherapy device Shenzhen Roundwhale Technology Co., Ltd. K192087 11/01/2019
electronic pulse stimulator Shenzhen Leading Perfection Technology Co., Ltd K183674 10/11/2019
nxpro neuromuscular electrical stimulation device NeuX Technologies, Inc. K191181 10/11/2019