Quell

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 Quell.

Pre-market Notification Details

• Device ID: K152954
• 510k Number: K152954
• Device Name: Quell
• Classification: Stimulator, Nerve, Transcutaneous, Over-the-counter
• Applicant: NEUROMETRIX, INC. 1000 WINTER STREET Waltham, MA 02451
• Contact: Rainer Maas
• Correspondent: Rainer Maas; NEUROMETRIX, INC. 1000 WINTER STREET 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: 2015-10-07
• Decision Date: 2016-01-05
• Summary: summary