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: K130919
• 510k Number: K130919
• 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: 2013-04-03
• Decision Date: 2013-07-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00851221006339	K130919	000
00851221006322	K130919	000
00851221006285	K130919	000
00851221006278	K130919	000