# K041575: Fenzian Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: Eumedic Limited
- Decided: Jul 16, 2004 after 32 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 K951951 (1996). 1 ancestor in all.
12 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951951: Focus Model 795 Unit, Empi (1996) Summary page 2.

## Most influential descendants
- K042912: INTERX5000 (2005), 10 descendants of its own
- K062641: Body-Stim, Biomodulator, Best-Rsi, Best Pro, Model Best-AV1 (2007), 2 descendants of its own
- K133779: CP Relief Wand (2014), 1 descendant of its own
- K092117: Scenar, Model 10 (2010), 1 descendant of its own
- K070217: Interx 1000/Derma 200 Stimulator for Cosmetic Use (2008), 1 descendant of its own

## Indications for use
TENS applications: * Symptomatic relief and management of chronic, intractable pain * Adjunctive treatment for post-surgical and post-trauma acute pain

Source page: https://510kreport.com/device/K041575
Methodology: https://510kreport.com/methodology