{"entity":{"id":"cooler-heads-care","kind":"company","name":"Cooler Heads Care","aka":["Cooler Heads","Amma scalp cooling"],"tldr":"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.","asOf":"2026-11-04","links":[{"label":"Official website","url":"https://coolerheads.com/"},{"label":"FDA 510(k) K211526: Portable Scalp Cooling System (Amma)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211526"}],"tags":["machines-wave3"],"related":[],"cancers":[],"sections":["rejuvenation","supportive-care"],"technologies":["scalp-cooling"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo machines inventory (openFDA, accessdata.fda.gov, ClinicalTrials.gov v2, Europe PMC, maker pages)","editedOn":"2026-11-04"},"hq":"San Diego, CA","country":"US","companyType":"devices","website":"https://coolerheads.com/","investors":[],"funding":[]},"route":"/companies/cooler-heads-care/","neighbours":{"section":[{"id":"rejuvenation","kind":"section","name":"Recovery & Rejuvenation","route":"/fronts/rejuvenation/"},{"id":"supportive-care","kind":"section","name":"Supportive Care & Survivorship","route":"/fronts/supportive-care/"}],"technology":[{"id":"scalp-cooling","kind":"technology","name":"Scalp cooling (cold caps: DigniCap, Paxman)","route":"/technologies/scalp-cooling/"}],"roadmap":[{"id":"chemo-chair-comfort-devices-roadmap","kind":"roadmap","name":"Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs","route":"/roadmaps/chemo-chair-comfort-devices-roadmap/"}],"idea":[{"id":"idea-mach-cooling-off-the-chair","kind":"idea","name":"Finish scalp cooling away from the infusion chair","route":"/ideas/idea-mach-cooling-off-the-chair/"}]}}