# Rochester Electro Medical, Inc.

- Location (FDA's records): Lutz, FL
- FDA decisions: 2 (2008–2015): 2 510(k) clearances
- Product codes: IKT (1), GXY (1)
- Predicates its devices cite: 8 (0 its own); citations of its devices by later devices: 1 (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
- Chalgren Enterprises, Inc.: 3 (https://510kreport.com/company/chalgren-enterprises)
- Dantec Electronics, Inc.: 1 (https://510kreport.com/company/dantec-electronics)
- Dantec Medical, Inc.: 1 (https://510kreport.com/company/dantec-medical)
- Cadwell Laboratories, Inc.: 1 (https://510kreport.com/company/cadwell-laboratories)
- Medicotest A/S: 1 (https://510kreport.com/company/medicotest-a-s)
- Xian Friendship Medical Electronics Co., Ltd.: 1 (https://510kreport.com/company/xian-friendship-medical-electronics)

## Firms that cite its devices most
- Embla Systems: 1 (https://510kreport.com/company/embla-systems)

## Its most-cited devices
- K142159: Disposable Pre-Gelled Surface Electrode (2015), cited by 1

## Recent decisions
- K142159: Disposable Pre-Gelled Surface Electrode (Jun 3, 2015)
- K080914: Ultrasharp Concentric Needles (Jul 15, 2008)

Source page: https://510kreport.com/company/rochester-electro-medical