510(k) K111767

NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT by Ness-Neuromuscular Electrical Stimulation Systems — Product Code GZI

K111767 is an FDA 510(k) premarket notification submitted by Ness-Neuromuscular Electrical Stimulation Systems for the device "NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT". The FDA issued a decision of Substantially Equivalent on September 15, 2011. The device falls under product code GZI (Stimulator, Neuromuscular, External Functional), a Class II device regulated under 21 CFR 882.5810. Ness-Neuromuscular Electrical Stimulation Systems has at least 6 other 510(k) clearances on record.