# DEN210046: Quell-FM

- Pathway: De Novo (Direct)
- Applicant: Neurometrix, Inc.
- Decided: May 18, 2022 after 225 days
- Product code: QSQ (Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms)
- Device class: 2
- Regulation: 21 CFR 882.5888
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Quell-FM is a transcutaneous electrical nerve stimulation (TENS) device indicated as an aid for reducing the symptoms of fibromyalgia in adults with high pain sensitivity. The Quell-FM may be used during sleep. The Quell-FM is labeled for use only with compatible NeuroMetrix electrodes.

Source page: https://510kreport.com/device/DEN210046
Methodology: https://510kreport.com/methodology