# K090922: Empi Active Transcutaneous Nerve Stimulator

- Pathway: 510(k) (Special)
- Applicant: Empi
- Decided: Jun 5, 2009 after 65 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: 3 generations back to K881114 (1988). 5 ancestors in all.
15 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)
- K061650: Select Tens, Model 4600S, Empi (2007) Summary page 1.

## Most influential descendants
- K121184: Sensus (2012), 14 descendants of its own
- 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

## Indications for use
The Empi Active Transcutaneous Nerve Stimulator Device is used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis It is also used as an adjunctive treatment for post-surgical and post-trauma acute pain.

Source page: https://510kreport.com/device/K090922
Methodology: https://510kreport.com/methodology