# K881114: Empi Model 989, Tens

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: Apr 15, 1988 after 31 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
No predicates in its family tree.
77 later devices descend from it; 2 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K970203: Epix VT (1997), 75 descendants of its own
- K061650: Select Tens, Model 4600S (2007), 56 descendants of its own
- K113037: Pain-Aid (2012), 33 descendants of its own
- K131159: Smartrelief (2013), 32 descendants of its own
- K093324: Empi Continuum (2010), 26 descendants of its own

Source page: https://510kreport.com/device/K881114
Methodology: https://510kreport.com/methodology