# Tuned, Ltd.

- Location (FDA's records): Gan Yoshiya, IL
- FDA decisions: 2 (2023–2025): 2 510(k) clearances
- Product codes: QUH (1), SCR (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)
- Apple, Inc.: 1 (https://510kreport.com/company/apple)

## Recent decisions
- K251208: Tuned Self-Fitting Mobile App (Sep 26, 2025)
- K223848: Intrisound™ Tuned Lumen® 155 Hearing Aids (Sep 8, 2023)

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