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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 K260142
Device Name StimelMD (SSMD) system
Applicant
Motion Informatics ltd.
Yarka Industrial Zone
Yarka,  IL 2496700
Applicant Contact Liora Levi
Correspondent
RA Regulation
25a Sirkin St.
Kfar Saba,  IL 4442157
Correspondent Contact Orly Maor
Regulation Number890.5850
Classification Product Code
IPF  
Date Received01/20/2026
Decision Date 05/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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