# K130919: Sensus

- Pathway: 510(k) (Traditional)
- Applicant: Neurometrix, Inc.
- Decided: Jul 2, 2013 after 90 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- 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: 5 generations back to K881114 (1988). 7 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121184: Sensus, Neurometrix, Inc. (2012) Summary page 1.

## Most influential descendants
- K140333: Ascend (2014), 11 descendants of its own
- K182203: JKH Stimulator Plus (2019), 7 descendants of its own
- K191151: JKH Stimulator Plus (2019), 4 descendants of its own
- K231569: ManaFlexx 2 (model: MF002-RX, MF002-OTC) (2023), 1 descendant of its own
- K202159: actiTENS (2020), 1 descendant of its own

## Indications for use
The NeuroMetrix SENSUS is intended for use as a transcutaneous electric 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 the NeuroMetrix SENSUS Electrode.

Source page: https://510kreport.com/device/K130919
Methodology: https://510kreport.com/methodology