# K042912: INTERX5000

- Pathway: 510(k) (Traditional)
- Applicant: Neuro Resource Group, Inc.
- Decided: May 17, 2005 after 208 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K951951 (1996). 3 ancestors in all.
10 later devices descend from it; 7 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)
- K041575: Fenzian Treatment System, Eumedic Limited (2004) Summary page 7.
- K951951: Focus Model 795 Unit, Empi (1996) Summary page 7.
- K870947: Dynatron 500, Dynatronics Corp. (1987) Summary page 7.

## Most influential descendants
- 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
- K053626: INTERX500 Flexible Array Electrode (2006), 1 descendant of its own

## Recalls of this device
- Feb 7, 2011 · Not classified · Z-2105-2011: Product package contains alcohol prep pads recalled by Triad Group because the prep pads have the potential to be contaminated with an objectionable organism.

## Indications for use
The InterX5000 is indicated for symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain.

Source page: https://510kreport.com/device/K042912
Methodology: https://510kreport.com/methodology