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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 223 Results
ProductCode: ngx Decision Date To: 05/21/2022
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wireless tens/ems, bruno, aela ZMI Elecronics Ltd. K220997 09/01/2022
cooltone Zimmer MedizinSysteme GmbH K220601 04/01/2022
cooltone Zimmer MedizinSysteme GmbH K192940 11/15/2019
emfieldpro Zimmer MedizinSysteme GmbH K182963 06/21/2019
xbody newave usa XBody Hungary Kft. K190038 04/05/2019
xbody go usa, xbody pro usa XBody Hungary Kft. K221200 01/31/2023
well life wireless tens/ems stimulator, models wr-2605/2605a WELL-LIFE HEALTHCARE LIMITED K161453 12/05/2016
well-life otc ems system WELL-LIFE HEALTHCARE LIMITED K102786 07/01/2011
otc abdomen & thigh system, model: wl-2410, wl-2411 and wl-2412 WELL-LIFE HEALTHCARE LIMITED K072168 12/19/2007
buttock muscle stimulator model wl-2413b; buttock muscle stimulator mode wl-2413e WELL-LIFE HEALTHCARE LIMITED K123075 07/11/2013