# K970203: Epix VT

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: Apr 14, 1997 after 83 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: 1 generation back to K881114 (1988). 2 ancestors in all.
75 later devices descend from it; 5 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)
- K881114: Empi Model 989, Tens, Empi (1988) Summary page 1.
- K951903: Epix XL Tens Unit, Empi (1996). Our OCR of the scanned summary read K951503, FDA’s number for CVD Bullett HI-Flo Infusion Catheter (Cardiovascular Dynamics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Empi Epix® XL TENS System”.

## Most influential descendants
- 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
- K124016: Empi Phoenix (2013), 25 descendants of its own

## Indications for use
The Epix® VT 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/K970203
Methodology: https://510kreport.com/methodology