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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K131513
Device Name SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY
Applicant
Ritm Okb Zao
99, Petrovskaya
Taganrog,  RU 347900
Applicant Contact LARISA SHPUNGINA
Correspondent
Ritm Okb Zao
99, Petrovskaya
Taganrog,  RU 347900
Correspondent Contact LARISA SHPUNGINA
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
GXY  
Date Received05/28/2013
Decision Date 07/11/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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