# K190115: MHD Tens

- Pathway: 510(k) (Traditional)
- Applicant: Minghuangda Electronic Co., Ltd.
- Decided: Jun 19, 2019 after 146 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: 1 generation back to K143268 (2015). 1 ancestor in all.
3 later devices descend from it; 2 cite 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)
- K143268: Tens and Powered Muscle Stimulator, Shenzhen As-Tec Technology Co., Ltd. (2015) Summary page 6.

## Most influential descendants
- K200727: TENS and Muscle Stimulator (2020), 1 descendant of its own
- K241678: TENS & EMS Stimulator (MHD-1083) (2024), 0 descendants of its own
- K201845: Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) (2020), 0 descendants of its own

## Indications for use
Transcutaneous Electrical Nerve Stimulation (Program 2, 3, 4, 6, 8, 9): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. Powered Muscle Stimulation (Program 1, 5, 7, 10, 11, 12): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Source page: https://510kreport.com/device/K190115
Methodology: https://510kreport.com/methodology