ENERGEX

Device, Discharge, Electrostatic (for Pain Relief)

ENERGEX SYSTEMS, INC.

The following data is part of a premarket notification filed by Energex Systems, Inc. with the FDA for Energex.

Pre-market Notification Details

• Device ID: K042686
• 510k Number: K042686
• Device Name: ENERGEX
• Classification: Device, Discharge, Electrostatic (for Pain Relief)
• Applicant: ENERGEX SYSTEMS, INC. 719 A STREET NE Washington, DC 20002
• Contact: Trish Landry
• Correspondent: Trish Landry; ENERGEX SYSTEMS, INC. 719 A STREET NE Washington, DC 20002
• Product Code: NHH
• CFR Regulation Number: 890.5500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-09-29
• Decision Date: 2005-06-16
• Summary: summary