# K952683: Apex Medical Corp. Portable Interferential Stimulation Device

- Pathway: 510(k) (Traditional)
- Applicant: Wholesale Medical Imports, Inc.
- Decided: Apr 1, 1997 after 659 days
- Product code: LIH (Interferential Current Therapy)
- 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 K921441 (1992). 1 ancestor in all.
33 later devices descend from it; 7 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921441: Interferential Stimulator Model Inf 4150/a, Biomedical Life Systems, Inc. (1992) Summary page 2.

## Most influential descendants
- K060246: Infrex (2006), 14 descendants of its own
- 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
- K032719: GM3 Series IF Tens, Model GM3X2IF (Where X IS a Parameter of Different Housing) (2003), 7 descendants of its own

## Indications for use
This device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic acute pain.

Source page: https://510kreport.com/device/K952683
Methodology: https://510kreport.com/methodology