# Zmi Electronics, Ltd.

- Location (FDA's records): Kaohsiung, TW
- FDA decisions: 3 (2018–2025): 3 510(k) clearances
- Product codes: KPI (2), GXY (1)
- 510(k) review time since 2016: median 268 days, against 172 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Wandy Rubber Industrial Co., Ltd.: 1 (https://510kreport.com/company/wandy-rubber-industrial)
- Gmdasz Manufacturing Co., Ltd.: 1 (https://510kreport.com/company/gmdasz-manufacturing)
- International Trade Group, Inc.: 1 (https://510kreport.com/company/international-trade-group)
- Ne Services, Ltd.: 1 (https://510kreport.com/company/ne-services)
- Well-Life Healthcare Limited: 1 (https://510kreport.com/company/well-life-healthcare)

## Firms that cite its devices most
- Guangdong Comytens Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/guangdong-comytens-medical-technology)
- Baisheng Medical Co., Ltd.: 1 (https://510kreport.com/company/baisheng-medical)
- Shenzhen Roundwhale Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-roundwhale-technology)

## Its most-cited devices
- K180865: ZMI Self-Adhesive Electrodes (2018), cited by 3

## Recent decisions
- K241862: Levina Pelvic Floor Muscle Stimulator (RS-48) (Mar 27, 2025)
- K231166: Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes (Jan 18, 2024)
- K180865: ZMI Self-Adhesive Electrodes (Jun 28, 2018)

Source page: https://510kreport.com/company/zmi-electronics