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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Neuromuscular, External Functional
510(k) Number K111767
Device Name NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT
Applicant
Ness-Neuromuscular Electrical Stimulation Systems
19 Ha'Haroshet St.
Ra'Anana,  IL 43654
Applicant Contact MONICA STACHURA,JD
Correspondent
Ness-Neuromuscular Electrical Stimulation Systems
19 Ha'Haroshet St.
Ra'Anana,  IL 43654
Correspondent Contact MONICA STACHURA,JD
Regulation Number882.5810
Classification Product Code
GZI  
Date Received06/23/2011
Decision Date 09/15/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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