# K003487: Stimate N601 Tens

- Pathway: 510(k) (Traditional)
- Applicant: Everyway Medical Instruments Co.,Ltd
- Decided: Jan 24, 2001 after 72 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K021794: Tatung TMD-26AX Series Tens, Models NO. TMD-26AB Tatung Tens (Blue Housing) TMD-26AY Tatung Tens (Yellow Housing) (2003), 1 descendant of its own
- K040311: Shian Jia Meei Digatal PWN Tens, Model YW-6000/UC-332/UC-330/ST-331 (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K003487
Methodology: https://510kreport.com/methodology