# K200727: TENS and Muscle Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Astec Technology Co., Ltd.
- Decided: Jun 18, 2020 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: 2 generations back to K143268 (2015). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 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.
- K190115: MHD Tens, Minghuangda Electronic Co., Ltd. (2019) Summary page 9.

## Most influential descendants
- K201845: Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) (2020), 0 descendants of its own

## Indications for use
TENS (Transcutaneous Electric Nerve Stimulation): 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. PMS (Powered Muscle Stimulation): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Source page: https://510kreport.com/device/K200727
Methodology: https://510kreport.com/methodology