# K210223: Transcutaneous Electrical Nerve Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Top-Rank Health Care Co., Ltd.
- Decided: Dec 15, 2021 after 321 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- 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 K102051 (2011). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152374: LL Tens 160A, LL Tens 160B, Fuji Dynamics, Ltd. (2016) Summary page 6.

## Most influential descendants
- K231425: Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) (2024), 1 descendant of its own
- K252688: Transcutaneous Electrical Nerve Stimulator (RJTENS-2) (2025), 0 descendants of its own

## Indications for use
The TOPTENS-01 can be used for the Symptomatic relief of chronic intractable pain, Post traumatic pain adjunctive treatment, Post-surgical pain adjunctive treatment.

Source page: https://510kreport.com/device/K210223
Methodology: https://510kreport.com/methodology