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U.S. Department of Health and Human Services

510(k) Premarket Notification

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111 to 120 of 219 Results
ProductCode: ngx Decision Date To: 05/21/2022
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katalyst mark 1 muscle stimulation system model 2 Katalyst Inc. K181199 09/20/2018
dual output digital therapy massager Shenzhen OSTO Technology Co., Ltd. K172834 09/06/2018
btl 799-2 BTL Industries, Inc. K180813 06/14/2018
electrical stimulator - model r-c1 tens and ems stimulator, model r-e1 ems stimulator, model r-t1 tens stimulator Shenzhen Roundwhale Technology Co., Ltd. K180956 06/07/2018
silk'n model h5003 device Home Skinovations Ltd. K180279 05/09/2018
wireless pain relieve device model: lt5018c Shenzhen Dongdixin Technology Co.,Ltd. K173462 12/08/2017
powerdot pd-01m Smartmissimo Technologies Pte Ltd K172876 12/04/2017
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