# K232439: Electrical Stimulator System

- Pathway: 510(k) (Traditional)
- Applicant: Gymmax Technology Shenzen Co., Ltd.
- Decided: Mar 21, 2024 after 220 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: 7 generations back to K940301 (1994). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 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 6.
- K133929: Health Expert Elctronic Stimulator, Shenzhen Osto Technology Company Limited (2014) Summary page 6.
- K130802: Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060), Shenzhen Dongdixin Technology Co., Ltd. (2013) Summary page 7.

## Indications for use
TENS (TENS 1 and TENS 2) To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities. PMS (STIM1 STIM2 STIM3 and STIM4) To stimulate healthy muscles in order to improve and facilitate muscle performance.

Source page: https://510kreport.com/device/K232439
Methodology: https://510kreport.com/methodology