510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN210046Unknown

Quell-FM

Neurometrix, Inc., Woburn MA / Direct, Unknown
FDA source (opens on fda.gov)

DEN210046 is the FDA 510(k) clearance record for Quell-FM, a class II device, cleared for Neurometrix, Inc. on under FDA product code QSQ (Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms). FDA's definition for product code QSQ reads: "Transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms". FDA records list 18 510(k) clearances for Neurometrix, Inc., from to . As of , FDA records show no recalls naming DEN210046.

Clearance record

Decision date
Received
(225 days to decision)
Product code
QSQ Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms
Regulation
21 CFR 882.5888
Device class
Class II
Review panel
Neurology
Applicant
Neurometrix, Inc. 4b Gill St., Woburn MA
Third party review
No

Clearances, product code QSQ

Trailing 12 months

FDA records hold no clearances under product code QSQ in the trailing twelve months.

FDA records show no clearances under product code QSQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QSQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260