# Advanced Cooling Therapy, Inc. D/B/A Attune Medical

- Location (FDA's records): Chicago, IL
- FDA decisions: 3 (2018–2023): 2 510(k) clearances and 1 De Novo grant
- Product codes: PLA (2), QXV (1)
- Predicates its devices cite: 3 (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
- Attune Medical: 2 (https://510kreport.com/company/attune-medical)

## Its most-cited devices
- K180244: EnsoETM (2018), cited by 1

## Recent decisions
- DEN230021: ensoETM (Sep 13, 2023)
- K180742: EnsoETM (May 17, 2018)
- K180244: EnsoETM (Feb 28, 2018)

Source page: https://510kreport.com/company/advanced-cooling-therapy-d-b-a-attune-medical