# Hei, Inc.

- Location (FDA's records): Boulder, CO
- FDA decisions: 1 (2012–2012): 1 510(k) clearance
- Product codes: LGZ (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Thermal Therapeutic Systems, Inc.: 1 (https://510kreport.com/company/thermal-therapeutic-systems)
- Belmont Instrument Corp.: 1 (https://510kreport.com/company/belmont-instrument)

## Recent decisions
- K102900: Heiter 3000 Hyperthermic Perfusion System (Mar 21, 2012)

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