Data / Medical devices / United States / Cooler Heads Care, Inc.
Cooler Heads Care, Inc.: FDA-registered device maker in San Diego, CA, United States, 1 510(k) clearance
Cooler Heads Care, Inc. is registered with the FDA (registration 3021619527) in San Diego, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 21, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3021619527
- Address
- 7197 Convoy Ct Ste 5, San Diego, CA, United States, 92111
- Owner or operator
- Cooler Heads Care, Inc. (10084301)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- February 7, 2022
- Registered through
- 2027
- Brand names listed
- AMMA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Scalp Cooling System | PMC | 2 | Complaint file establishment, Manufacturer, 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 |
|---|---|---|---|---|---|---|
| October 21, 2021 | K211526 | Portable Scalp Cooling System | PMC | Substantially Equivalent | Cooler Heads Care, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 21, 2021. 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.