H-WAVE

Stimulator, Muscle, Powered

ELECTRONIC WAVEFORM LABORATORY, INC.

The following data is part of a premarket notification filed by Electronic Waveform Laboratory, Inc. with the FDA for H-wave.

Pre-market Notification Details

• Device ID: K103738
• 510k Number: K103738
• Device Name: H-WAVE
• Classification: Stimulator, Muscle, Powered
• Applicant: ELECTRONIC WAVEFORM LABORATORY, INC. 16168 BEACH BLVD., SUITE 232 Huntington Beach, CA 92647
• Contact: Ryan P Heaney
• Correspondent: Ryan P Heaney; ELECTRONIC WAVEFORM LABORATORY, INC. 16168 BEACH BLVD., SUITE 232 Huntington Beach, CA 92647
• Product Code: IPF
• CFR Regulation Number: 890.5850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-12-22
• Decision Date: 2011-06-01
• Summary: summary