# Cooler Heads Care

Source: https://onco.cc/companies/cooler-heads-care/  
OnCo record `cooler-heads-care` (Company). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Cooler Heads makes Amma, a portable scalp-cooling system cleared by the FDA in 2021 that a patient can wear away from the infusion chair.

## Summary

Cooler Heads Care of San Diego received 510(k) K211526 on 21 October 2021 for its Portable Scalp Cooling System, listed as Amma, to reduce the likelihood of chemotherapy-induced alopecia in adults with solid tumours; the summary says it is "indicated for home use" and names the Paxman Scalp Cooler as predicate. A portable cooler bears on the chair time that tethered machines add to each infusion day.

## Fields

- Kind: Company
- Last checked: 2026-11-04
- Also known as: Cooler Heads; Amma scalp cooling
- Tags: machines-wave3
- HQ: San Diego, CA
- Type: devices
- Website: https://coolerheads.com/

## Sources

- Official website: https://coolerheads.com/
- FDA 510(k) K211526: Portable Scalp Cooling System (Amma): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211526

## Connected records

- fronts: [Recovery & Rejuvenation](https://onco.cc/fronts/rejuvenation/), [Supportive Care & Survivorship](https://onco.cc/fronts/supportive-care/)
- technologies: [Scalp cooling (cold caps: DigniCap, Paxman)](https://onco.cc/technologies/scalp-cooling/)
- roadmaps: [Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs](https://onco.cc/roadmaps/chemo-chair-comfort-devices-roadmap/)
- ideas: [Finish scalp cooling away from the infusion chair](https://onco.cc/ideas/idea-mach-cooling-off-the-chair/)

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