SENSUS

Stimulator, Nerve, Transcutaneous, For Pain Relief

NEUROMETRIX, INC.

The following data is part of a premarket notification filed by Neurometrix, Inc. with the FDA for Sensus.

Pre-market Notification Details

• Device ID: K121184
• 510k Number: K121184
• Device Name: SENSUS
• Classification: Stimulator, Nerve, Transcutaneous, For Pain Relief
• Applicant: NEUROMETRIX, INC. 62 FOURTH AVE. Waltham, MA 02451
• Contact: Rainer Maas
• Correspondent: Rainer Maas; NEUROMETRIX, INC. 62 FOURTH AVE. Waltham, MA 02451
• Product Code: GZJ
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-04-18
• Decision Date: 2012-08-02
• Summary: summary