# K192201: Electrical Stimulator System

- Pathway: 510(k) (Traditional)
- Applicant: Gymmax Technology Shenzen Co., Ltd.
- Decided: Jun 12, 2020 after 304 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 K153520 (2016). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153520: Electronic Pulse Stimulator, Jkh Health Co., Ltd. (2016) Summary page 4.

## Indications for use
TENS (Modes 1 and 6) 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. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. PMS (Modes 2, 3, 4 and 5) To stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. It is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

Source page: https://510kreport.com/device/K192201
Methodology: https://510kreport.com/methodology