E-PULSE

Stimulator, Electro-acupuncture

MEDEVICE CORPORATION

The following data is part of a premarket notification filed by Medevice Corporation with the FDA for E-pulse.

Pre-market Notification Details

• Device ID: K091875
• 510k Number: K091875
• Device Name: E-PULSE
• Classification: Stimulator, Electro-acupuncture
• Applicant: MEDEVICE CORPORATION 11 NE 15TH AVE Pompano Beach, FL 33060
• Contact: Tzvi Milshtein
• Correspondent: Tzvi Milshtein; MEDEVICE CORPORATION 11 NE 15TH AVE Pompano Beach, FL 33060
• Product Code: BWK
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-06-23
• Decision Date: 2009-12-07
• Summary: summary