# Hearx SA (Pty), Ltd.

- Location (FDA's records): Pretoria, ZA
- FDA decisions: 2 (2023–2023): 2 510(k) clearances
- Product codes: QUH (1), EWO (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: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Kaz USA, Inc., A Helen of Troy Company: 1 (https://510kreport.com/company/kaz-usa-a-helen-of-troy)
- Otodynamics, Ltd.: 1 (https://510kreport.com/company/otodynamics)

## Recent decisions
- K231545: hearOAE (Oct 27, 2023)
- K223137: Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application (Mar 14, 2023)

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