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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, muscle, powered
510(k) Number K233926
Device Name accufit
Applicant
Mettler Electronics Corporation
1333 South Claudina St
Anaheim,  CA  92805
Applicant Contact An Le
Correspondent
Lutronic Corporation
Lutronic Center
219, Sowon-Ro
Deogyang-Gu,  KR 410220
Correspondent Contact Kevin O'Connell
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
NGX  
Date Received12/13/2023
Decision Date 03/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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