510(k) K103738

H-WAVE by Electronic Waveform Laboratory, Inc. — Product Code IPF

K103738 is an FDA 510(k) premarket notification submitted by Electronic Waveform Laboratory, Inc. for the device "H-WAVE". The FDA issued a decision of Substantially Equivalent on June 1, 2011. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Electronic Waveform Laboratory, Inc. has at least 5 other 510(k) clearances on record.