RELIEFBAND

Stimulator, Nerve, Transcutaneous, For Pain Relief

WOODSIDE BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Woodside Biomedical, Inc. with the FDA for Reliefband.

Pre-market Notification Details

• Device ID: K980333
• 510k Number: K980333
• Device Name: RELIEFBAND
• Classification: Stimulator, Nerve, Transcutaneous, For Pain Relief
• Applicant: WOODSIDE BIOMEDICAL, INC. 18140 SMOKESIGNAL DR. San Diego, CA 92127
• Contact: Carol Patterson
• Correspondent: Carol Patterson; WOODSIDE BIOMEDICAL, INC. 18140 SMOKESIGNAL DR. San Diego, CA 92127
• Product Code: GZJ
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-01-28
• Decision Date: 1998-02-18
• Summary: summary