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U.S. Department of Health and Human Services

510(k) Premarket Notification

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91 to 100 of 212 Results
ProductCode: ngx Decision Date To: 05/21/2022
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everyway wireless tens & ems unit Everyway Medical Instruments Co., Ltd. K181707 09/26/2018
katalyst mark 1 muscle stimulation system model 2 Katalyst Inc. K181199 09/20/2018
powerdot pd-01mt Smartmissimo Technologies Pte Ltd K181759 11/09/2018
slendertone corefit abs 8, type 734 Bio-Medical Research Ltd K180688 10/25/2018
btl 799-2t BTL Industries, Inc. K182106 10/23/2018
emfieldpro Zimmer MedizinSysteme GmbH K182963 06/21/2019
portable electro-stimulation therapy device Guangzhou Longest Science & Technology Co., Ltd. K182020 09/17/2020
tyece otc ems system Tyece Ltd. K183454 02/26/2019
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
electronic pulse stimulator Shenzhen Leading Perfection Technology Co., Ltd K183674 10/11/2019
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