INWAVE

Stimulator, Electrical, Non-implantable, For Incontinence

ZYNEX MEDICAL, INC.

The following data is part of a premarket notification filed by Zynex Medical, Inc. with the FDA for Inwave.

Pre-market Notification Details

• Device ID: K121820
• 510k Number: K121820
• Device Name: INWAVE
• Classification: Stimulator, Electrical, Non-implantable, For Incontinence
• Applicant: ZYNEX MEDICAL, INC. 9990 Park Meadows Dr. Lone Tree, CO 80124
• Contact: Jim Arnold
• Correspondent: Jim Arnold; ZYNEX MEDICAL, INC. 9990 Park Meadows Dr. Lone Tree, CO 80124
• Product Code: KPI
• CFR Regulation Number: 876.5320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-06-21
• Decision Date: 2012-08-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00852670007052	K121820	000