ASCEND

Stimulator, Nerve, Transcutaneous, Over-the-counter

NEUROMETRIX, INC.

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

Pre-market Notification Details

• Device ID: K140333
• 510k Number: K140333
• Device Name: ASCEND
• Classification: Stimulator, Nerve, Transcutaneous, Over-the-counter
• 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: NUH
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-02-10
• Decision Date: 2014-07-03
• Summary: summary