DeviceClearance

Product code QSQ— Neurology

Quell-FM

Classification name
Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms
Device class
Class 2
Regulation
21 CFR 882.5888
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

FDA classification definition

“Transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms.”

— U.S. Food and Drug Administration, device classification record for product code QSQ under 21 CFR 882.5888, via openFDA

Market context for product code QSQ

FDA has cleared 1 device under product code QSQ, all in 2022, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QSQ

Recent clearances under product code QSQ

Data sourced from openFDA. This site is unofficial and independent of the FDA.