H-WAVE

Stimulator, Nerve, Transcutaneous, For Pain Relief

ELECTRONIC WAVEFORM LAB, INC.

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

Pre-market Notification Details

• Device ID: K112485
• 510k Number: K112485
• Device Name: H-WAVE
• Classification: Stimulator, Nerve, Transcutaneous, For Pain Relief
• Applicant: ELECTRONIC WAVEFORM LAB, INC. 5702 BOLSA AVE. Huntington Beach, CA 92649
• Contact: Ryan P Heaney
• Correspondent: Ryan P Heaney; ELECTRONIC WAVEFORM LAB, INC. 5702 BOLSA AVE. Huntington Beach, CA 92649
• Product Code: GZJ
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-08-29
• Decision Date: 2011-12-06
• Summary: summary