# Electromed, Inc.

- Location (FDA's records): New Prague, MN
- FDA decisions: 6 (1999–2022): 6 510(k) clearances
- Names in FDA's records: Electromed, Inc. (5); Electromed Corp. (1)
- Product codes: BYI (5), ISD (1)
- Predicates its devices cite: 6 (4 its own); citations of its devices by later devices: 6 (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
- Lode Corp.: 1 (https://510kreport.com/company/lode)
- American Biosystems, Inc.: 1 (https://510kreport.com/company/american-biosystems)

## Firms that cite its devices most
- International Biophysics Corp.: 1 (https://510kreport.com/company/international-biophysics)
- Dymedso, Inc.: 1 (https://510kreport.com/company/dymedso)

## Its most-cited devices
- K053248: Smartvest Airway Clearance System, Model TL (2005), cited by 2
- K982889: Medpulse Respiratory Vest System, Model 1000 (1999), cited by 2
- K132794: Smartvest Airway Clearance System (2013), cited by 1
- K040367: Medpulse Respiratory Vest System, Model 2000EZ (2004), cited by 1

## Recent decisions
- K222496: Electromed SmartVest Airway Clearance System (Nov 18, 2022)
- K132794: Smartvest Airway Clearance System (Dec 19, 2013)
- K053248: Smartvest Airway Clearance System, Model TL (Dec 1, 2005)
- K040367: Medpulse Respiratory Vest System, Model 2000EZ (Apr 7, 2004)
- K982889: Medpulse Respiratory Vest System, Model 1000 (Jun 1, 1999)
- K990813: Rehcor (Apr 12, 1999)

Source page: https://510kreport.com/company/electromed