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U.S. Department of Health and Human Services

510(k) Premarket Notification

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111 to 120 of 212 Results
ProductCode: ngx Decision Date To: 05/21/2022
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hivox otc electrical stimulator Hivox Biotek Inc. K171803 11/29/2017
tyece otc ems system, model em35 Tyece Ltd. K172241 11/20/2017
dr.music 3s SmartMedicalDevice Co., Ltd. K172451 11/17/2017
mytens model: bw-tsx Bewell Connect Corp. K171026 11/01/2017
otc combo tens/ems system Well-Life Healthcare Limited K172809 10/18/2017
pain therapy device Guangzhou Xinbo Electronic Co., Ltd. K163611 09/19/2017
katalyst mark 1 muscle stimulation system Katalyst Inc. K171035 09/06/2017
hi-dow wireless tens/ems system (model hd-sn) Hi-Dow International, Inc. K163393 08/04/2017
everyway otc ems, model ev-805 EVERYWAY MEDICAL INSTRUMENT CO., LTD. K162744 08/03/2017
xiniwave ii model ecs322p International Trade Group, Inc. K171092 07/10/2017