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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, for muscle conditioning
510(k) Number K211298
Device Name WiEMSpro
Applicant
Medical Cables S.L.
Calle Ferrocarril del Puerto 18 - Oficina 3-4
Málaga,  ES 29002
Applicant Contact José Fuertes Peña
Correspondent
Medical Cables S.L.
Calle Ferrocarril del Puerto 18 - Oficina 3-4
Málaga,  ES 29002
Correspondent Contact José Fuertes Peña
Regulation Number890.5850
Classification Product Code
NGX  
Date Received04/28/2021
Decision Date 08/25/2022
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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