# K241119: Transcutaneous Electrical Nerve Stimulator (K6106)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Yicai Health Technology Co., Ltd.
- Decided: Jul 22, 2024 after 90 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: 9 generations back to K881114 (1988). 71 ancestors in all.
No later device cites it as a predicate yet.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171803: HIVOX OTC Electrical Stimulator, Hivox Biotek, Inc. (2017) Summary page 5.
- K192264: HIVOX Spopad EMS SP-911, SP-921, Hivox Biotek, Inc. (2019) Summary page 5.
- K201354: Tens & PMS, Hong Qiangxing (Shenzhen) Electronics Limited (2020) Summary page 5.
- K191151: JKH Stimulator Plus, Jkh USA, LLC (2019) Summary page 5.

## Indications for use
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Source page: https://510kreport.com/device/K241119
Methodology: https://510kreport.com/methodology