Data / Medical devices / United States / Advanced Cooling Therapy, LLC
Advanced Cooling Therapy, LLC: FDA-registered device maker in Boston, MA, United States, 3 510(k) clearances
Advanced Cooling Therapy, LLC is registered with the FDA (registration 3010412492) in Boston, MA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 13, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010412492
- Address
- 125 Summer St, Boston, MA, United States, 02110
- Owner or operator
- Advanced Cooling Therapy, LLC d/b/a "Attune Medical" (10044486)
- Roles
- Specification developer
- First device listed
- October 31, 2017
- Registered through
- 2026
- Brand names listed
- EnsoETM, ensoETM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Esophageal Thermal Regulation And Gastric Suctioning Device | PLA | 2 | Specification developer | accessdata.fda.gov |
| Temperature Regulation Device For Esophageal Protection During Cardiac Ablation | QXV | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 13, 2023 | DEN230021 | ensoETM | QXV | Unknown | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | accessdata.fda.gov |
| February 28, 2018 | K180244 | EnsoETM | PLA | Substantially Equivalent | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | accessdata.fda.gov |
| October 17, 2017 | K172493 | EnsoETM | PLA | Substantially Equivalent | Attune Medical | accessdata.fda.gov |
Updated September 13, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.