# K121184: Sensus

- Pathway: 510(k) (Traditional)
- Applicant: Neurometrix, Inc.
- Decided: Aug 2, 2012 after 106 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: 4 generations back to K881114 (1988). 6 ancestors in all.
14 later devices descend from it; 1 cites 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)
- K090922: Empi Active Transcutaneous Nerve Stimulator, Empi (2009) Summary page 1.

## Most influential descendants
- K130919: Sensus (2013), 13 descendants of its own
- 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

## 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.

Source page: https://510kreport.com/device/K121184
Methodology: https://510kreport.com/methodology