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U.S. Department of Health and Human Services

510(k) Premarket Notification

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71 to 80 of 212 Results
ProductCode: ngx Decision Date To: 05/21/2022
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low-frequency multi-function physiotherapy instrument (model: ktr-2230, ktr-2220, ktr-2210, ktr-2231, ktr-2221, ktr-2211, ktr-2232, ktr-2222, ktr-2212) Shenzhen Kentro Medical Electronics Co., Ltd K191982 09/25/2020
msls6qf tens/pms device Self Doctor Care, LLC K193655 09/04/2020
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
electrical stimulator system Gymmax Technology Shenzen Co., Ltd. K192201 06/12/2020
fastfit ems system Fast Fit LLC K192161 01/22/2020
jkh stimulator plus JKH USA, LLC K191151 06/21/2019
katalyst training system Katalyst Inc. K190966 02/03/2020