# Sein Electronics Co., Ltd.

- Location (FDA's records): Mahwah, NJ
- FDA decisions: 12 (1991–2005): 12 510(k) clearances
- Product codes: DXN (9), NBW (1), GZJ (1), DPW (1)
- Predicates its devices cite: 6 (4 its own); citations of its devices by later devices: 9 (4 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
- Taidoc Technology Corporation: 1 (https://510kreport.com/company/taidoc-technology)
- Selfcare, Inc.: 1 (https://510kreport.com/company/selfcare)

## Firms that cite its devices most
- Genexel-Sein, Inc.: 2 (https://510kreport.com/company/genexel-sein)
- Hubdic Co., Ltd.: 1 (https://510kreport.com/company/hubdic)
- Meditec Co., Ltd.: 1 (https://510kreport.com/company/meditec)
- Genexel Medical Instrument, Inc.: 1 (https://510kreport.com/company/genexel-medical-instrument)

## Its most-cited devices
- K012054: Full Auto Wrist Digital Blood Pressure Monitor, Model SE-312 (2001), cited by 3
- K052108: Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100 (2005), cited by 2
- K952826: Full Auto Fuzzy Blood Pressure Meter Model SE-7000 (1996), cited by 1
- K032927: Full Auto Arm Digital Blood Pressure Monitor (2004), cited by 1
- K042138: Full Auto Wrist Digital Blood Pressure Monitor Model# SE-311 (2004), cited by 1
- K003282: Full Auto Blood Pressure Monitor, Model SE-7700H (2000), cited by 1

## Recent decisions
- K052108: Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100 (Dec 7, 2005)
- K042138: Full Auto Wrist Digital Blood Pressure Monitor Model# SE-311 (Aug 24, 2004)
- K042014: Digital Blood Pressure Monitor, Models SE-9000, SE-9200 and SE-9400 (Aug 6, 2004)
- K032927: Full Auto Arm Digital Blood Pressure Monitor (May 7, 2004)
- K012054: Full Auto Wrist Digital Blood Pressure Monitor, Model SE-312 (Aug 8, 2001)
- K003711: Ambulatory Blood Pressure Monitoring System, Model SE-25M/25P (Dec 15, 2000)
- K003282: Full Auto Blood Pressure Monitor, Model SE-7700H (Nov 1, 2000)
- K991397: Transcutaneous Electrical Nerve Stimulator SE-30 Tens (Feb 11, 2000)

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