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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 20 of 249 Results
ProductCode: ngx Decision Date To: 02/25/2017
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combo electrotherapy device (models: r-c101c, r-c101d, r-c101f, r-c101g, f100, mini-tens-comb, rc101i, tens3500) Shenzhen Roundwhale Technology Co. Ltd. K231423 01/22/2024
hi-dow pro touch wireless 6-12 (hd-19a) Hi-Dow International, Inc. K233461 01/19/2024
electronic muscle stimulator (model mp01) Shenzhen Hengbosi Industrial Co., Ltd. K233035 01/08/2024
ems neck massager Xiamen Comfier Technology Co., Ltd K233492 12/20/2023
deka lily El.En. S.p.A. K233470 12/19/2023
sofwave system Sofwave Medical Ltd. K232455 12/14/2023
manaflexx 2 (model: mf002-rx, mf002-otc) ManaMed, Inc K231569 11/03/2023
legend x platform Pollogen Ltd K232903 10/17/2023
starformer, tightwave Fotona d.o.o. K221274 09/29/2023
hi-emt magshape Beijing Sano Laser S&T Development Co., Ltd K230024 09/06/2023
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