# K040512: Limited Function WL/Otc-Tens Device, Model WL-2103A, WL-2203A, WL-2203B and WL-2401

- Pathway: 510(k) (Traditional)
- Applicant: Well-Life Healthcare, Inc.
- Decided: May 27, 2004 after 90 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.
82 later devices descend from it; 4 cite it directly.
0 of 83 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
- K112392: Hivox Biotek Inc. (2012), 58 descendants of its own
- K122744: Prospera Otc Tens Electronic Pulse Massager (2013), 55 descendants of its own
- K133929: Health Expert Elctronic Stimulator (2014), 26 descendants of its own
- K143207: Revitive IX (OTC) (2015), 17 descendants of its own
- K060222: Low Back Pain Relief System /Models GM310PP,GM320PP,GM321PP, and GM330PP (2006), 14 descendants of its own

## Indications for use
The model WL-2402, WL-2403 TENS are intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. The model WL-2401 TENS is indicated for use in the relief of nausea and vomiting due to motion sickness, and for the relief of mild to moderate nausea and vomiting associated with pregnancy.

Source page: https://510kreport.com/device/K040512
Methodology: https://510kreport.com/methodology