510(k) K123636

H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE by Bioness, Inc. — Product Code GZI

K123636 is an FDA 510(k) premarket notification submitted by Bioness, Inc. for the device "H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE". The FDA issued a decision of Substantially Equivalent on May 1, 2013. The device falls under product code GZI (Stimulator, Neuromuscular, External Functional), a Class II device regulated under 21 CFR 882.5810. Bioness, Inc. has at least 10 other 510(k) clearances on record.