PREMIER PLUS

Stimulator, Nerve, Transcutaneous, For Pain Relief

AMERICAN IMEX

The following data is part of a premarket notification filed by American Imex with the FDA for Premier Plus.

Pre-market Notification Details

• Device ID: K032003
• 510k Number: K032003
• Device Name: PREMIER PLUS
• Classification: Stimulator, Nerve, Transcutaneous, For Pain Relief
• Applicant: AMERICAN IMEX 16520 ASTON ST. Irvine, CA 92606
• Contact: Alex Fong
• Correspondent: Alex Fong; AMERICAN IMEX 16520 ASTON ST. Irvine, CA 92606
• Product Code: GZJ
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-06-27
• Decision Date: 2004-01-07