# K060246: Infrex

- Pathway: 510(k) (Traditional)
- Applicant: Johari Digital Healthcare, Ltd.
- Decided: May 5, 2006 after 94 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: 2 generations back to K921441 (1992). 3 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021755: Apex Medical Digital Tens TS1211, TS1212, Apex Medical Corp. (2002) Summary page 2.
- K952683: Apex Medical Corp. Portable Interferential Stimulation Device, Wholesale Medical Imports, Inc. (1997) Summary page 2.

## Most influential descendants
- K072123: Homewave Neuromodulations Pain Therapy Device (2008), 11 descendants of its own
- K161154: Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs (2016), 9 descendants of its own
- K170902: Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit (2017), 7 descendants of its own
- K181422: SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit (2018), 6 descendants of its own
- K202660: SPRINT PNS System (2021), 5 descendants of its own

## Indications for use
INFREX is indicated to be used for: * Symptomatic relief and management of chronic intractable pain. • Adjunctive treatment in the management of post surgical and post-traumatic, Acute pain condition.

Source page: https://510kreport.com/device/K060246
Methodology: https://510kreport.com/methodology