TRUWAVE

Stimulator, Nerve, Transcutaneous, For Pain Relief

DAN MED, INC.

The following data is part of a premarket notification filed by Dan Med, Inc. with the FDA for Truwave.

Pre-market Notification Details

• Device ID: K013210
• 510k Number: K013210
• Device Name: TRUWAVE
• Classification: Stimulator, Nerve, Transcutaneous, For Pain Relief
• Applicant: DAN MED, INC. 4 WEST DRY CREEK CIRCLE, SUITE 260 Denver, CO 80120
• Contact: Thomas Sandgaard
• Correspondent: Thomas Sandgaard; DAN MED, INC. 4 WEST DRY CREEK CIRCLE, SUITE 260 Denver, CO 80120
• Product Code: GZJ
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-09-26
• Decision Date: 2002-04-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00852670007021	K013210	000