# Gmdasz Manufacturing Co., Ltd.

- Location (FDA's records): Echo, OR
- FDA decisions: 2 (2009–2016): 2 510(k) clearances
- Product codes: GXY (2)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 6 (1 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
- Axelgaard Mfg. Co., Ltd.: 1 (https://510kreport.com/company/axelgaard-mfg)
- Naimco, Inc.: 1 (https://510kreport.com/company/naimco)
- Wandy Rubber Industrial Co., Ltd.: 1 (https://510kreport.com/company/wandy-rubber-industrial)

## Firms that cite its devices most
- Zmi Electronics, Ltd.: 1 (https://510kreport.com/company/zmi-electronics)
- Voncare Medical Device Co., Ltd.: 1 (https://510kreport.com/company/voncare-medical-device)
- Shenzhen Roundwhale Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-roundwhale-technology)
- South Dakota Partners: 1 (https://510kreport.com/company/south-dakota-partners)
- Shenzhen Quality Medical Technology Co.,Ltd: 1 (https://510kreport.com/company/shenzhen-quality-medical-technology)

## Its most-cited devices
- K160138: Adhesive Electrodes (2016), cited by 5
- K092546: Gmdasz Tens Electrodes, Models CWN1005, Dia. 5CM, DWN2505, 5CMX5CM, CWN1007.Dia. 7CM, CWN2509,5CMX9CM (2009), cited by 1

## Recent decisions
- K160138: Adhesive Electrodes (Aug 11, 2016)
- K092546: Gmdasz Tens Electrodes, Models CWN1005, Dia. 5CM, DWN2505, 5CMX5CM, CWN1007.Dia. 7CM, CWN2509,5CMX9CM (Dec 18, 2009)

Source page: https://510kreport.com/company/gmdasz-manufacturing