# K040311: Shian Jia Meei Digatal PWN Tens, Model YW-6000/UC-332/UC-330/ST-331

- Pathway: 510(k) (Traditional)
- Applicant: Shian Jia Meei Enterprise Co., Ltd.
- Decided: Oct 1, 2004 after 235 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 K003487 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021794: Tatung TMD-26AX Series Tens, Models NO. TMD-26AB Tatung Tens (Blue Housing) TMD-26AY Tatung Tens (Yellow Housing), Tatung Co. (2003) Summary page 1.

## Indications for use
The SHIAN JIA MEEI DIGITAL PWM TENS is intended for symptomatic relief and management of chronic intractable pain.

Source page: https://510kreport.com/device/K040311
Methodology: https://510kreport.com/methodology