# Ni Medical

- Location (FDA's records): Warrington, PA
- FDA decisions: 3 (1997–2009): 3 510(k) clearances
- Names in FDA's records: Ni Medical (2); N.I. Medical, Ltd. (1)
- Product codes: DSB (2), DRX (1)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 1 (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
- C.L. Mcintosh & Assoc., Inc.: 2 (https://510kreport.com/company/cl-mcintosh-assoc)
- Cardiodynamics International Corp.: 1 (https://510kreport.com/company/cardiodynamics-international)
- Katecho, Inc.: 1 (https://510kreport.com/company/katecho)

## Its most-cited devices
- K070500: Bioimpedance Cardiac Analyzing Measuring System, Model Nicas 2004 Slim (2007), cited by 1

## Recent decisions
- K080941: Bioimpedance Cardiac Analyzing Measuring System (Jun 18, 2009)
- K070500: Bioimpedance Cardiac Analyzing Measuring System, Model Nicas 2004 Slim (Jul 16, 2007)
- K972001: Nicas (TM) Electrode (Jul 8, 1997)

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