# K021755: Apex Medical Digital Tens TS1211, TS1212

- Pathway: 510(k) (Special)
- Applicant: Apex Medical Corp.
- Decided: Jun 12, 2002 after 14 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
No predicates in its family tree.
25 later devices descend from it; 6 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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
- K181422: SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit (2018), 6 descendants of its own

## Indications for use
Apex Medical Digital TENS is intended to be used in symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain.

Source page: https://510kreport.com/device/K021755
Methodology: https://510kreport.com/methodology