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510(k) DEN210046

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

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)