# K152954: Quell

- Pathway: 510(k) (Traditional)
- Applicant: Neurometrix, Inc.
- Decided: Jan 5, 2016 after 90 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K881114 (1988). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140333: Ascend, Neurometrix, Inc. (2014) Summary page 4.

## Indications for use
Quell is intended for use as a transcutaneous electrical nerve stimulation device for temporary relief of pain associated with sore and aching muscles in the lower extremities due to strain from exercise or normal household and work activities. Quell is intended for use as a transcutaneous electrical nerve stimulation device for the symptomatic relief and management of chronic intractable pain. The device may be used during sleep. The device is labeled for use only with compatible NeuroMetrix electrodes.

Source page: https://510kreport.com/device/K152954
Methodology: https://510kreport.com/methodology