# K951903: Epix XL Tens Unit

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: Mar 20, 1996 after 331 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.
76 later devices descend from it; 3 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Empi Epix XL Model 989: named in the summary without a submission number

## 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

## Indications for use
The Epix XL TENS Unit is indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.

Source page: https://510kreport.com/device/K951903
Methodology: https://510kreport.com/methodology