• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
1 to 10 of 212 Results
ProductCode: ngx Decision Date To: 05/21/2022
Results per Page
New Search  
Export all 212 Records to ExcelExport to Excel | Download Files | More About 510(k)
Device Name
Sort by Device Name [A-Z]
Sort by Device Name [Z-A]
Sort by Applicant [A-Z]
Sort by Applicant [Z-A]
Sort by 510(k) Number [0-9]
Sort by 510(k) Number [9-0]
Sort by Decision Date [0-9]
Sort by Decision Date [9-0]
wireless tens/ems, bruno, aela ZMI Elecronics Ltd. K220997 09/01/2022
emfieldpro Zimmer MedizinSysteme GmbH K182963 06/21/2019
cooltone Zimmer MedizinSysteme GmbH K220601 04/01/2022
cooltone Zimmer MedizinSysteme GmbH K192940 11/15/2019
xbody newave usa XBody Hungary Kft. K190038 04/05/2019
buttock muscle stimulator model wl-2413b; buttock muscle stimulator mode wl-2413e WELL-LIFE HEALTHCARE LIMITED K123075 07/11/2013
well life wireless tens/ems stimulator, models wr-2605/2605a WELL-LIFE HEALTHCARE LIMITED K161453 12/05/2016
well-life tens/ems/heating stimulator Well-Life Healthcare Limited K213091 02/19/2022
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