# K100399: 4 Channels Multiple Model Digital Electrical Stimulator, Model Nuvostim IV, WL-2504A

- Pathway: 510(k) (Special)
- Applicant: Well-Life Healthcare Limited
- Decided: Jun 25, 2010 after 129 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: 7 generations back to K921441 (1992). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033857: T-Tech Digital, Model WL-22XXA Series, Well-Life Healthcare, Inc. (2003) Summary page 1.
- K092763: IF True Sine Interferential Stimulator, WL-2206D, Well-Life Healthcare Limited (2009) Summary page 1.

## Indications for use
The indication for use of this device includes the prescription TENS, NMS, Interferential stimulation as follows: Transcutaneous Electrical Nerve Stimulator (TENS/IF TENS) & Program can be used for the following applications : For symptomatic relief of chronic intractable pain. Neuromuscular electrical stimulation (NMS) & Program stimulation can be used for the following applications: * Relax muscle spasms * Prevent or retard disuse atrophy * Increase local blood circulation * Re-educate muscles * Maintain or increase the range of motion

Source page: https://510kreport.com/device/K100399
Methodology: https://510kreport.com/methodology