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510(k) DEN210046

Quell-FM by Neurometrix, Inc. — Product Code QSQ

DEN210046 is an FDA 510(k) premarket notification submitted by Neurometrix, Inc. for the device "Quell-FM". The FDA issued a decision of De Novo Granted on May 18, 2022. The device falls under product code QSQ (Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms), a Class II device regulated under 21 CFR 882.5888. Neurometrix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
May 18, 2022
Date Received
October 5, 2021
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms
Device Class
Class II
Regulation Number
882.5888
Review Panel
NE
Submission Type

Transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms.

Other clearances by Neurometrix, Inc.

  • K152954 — Quell (January 5, 2016)
  • K140586 — ASCEND ELECTRODE (November 17, 2014)
  • K140333 — ASCEND (July 3, 2014)
  • K130919 — SENSUS (July 2, 2013)
  • K121816 — SENSUS ELECTRODE (November 26, 2012)
  • K121184 — SENSUS (August 2, 2012)
  • K091155 — ASCEND (September 3, 2009)
  • K083322 — NEUROMETRIX BIOAMPLIFIER (May 27, 2009)
  • K083818 — UNIVERSAL ELECTRODES (January 21, 2009)
  • K081871 — UNIVERSAL ELECTRODES (September 29, 2008)

FDA data resources