# Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs

Source: https://onco.cc/roadmaps/chemo-chair-comfort-devices-roadmap/  
OnCo record `chemo-chair-comfort-devices-roadmap` (Roadmap). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The devices that make the hours in the chemotherapy chair more bearable and protect hair, nails and nerves: frozen caps, then refrigerated scalp-cooling machines cleared from 2015, portable coolers, cooling and compression for hands and feet, and the chair itself.

## Summary

Seven devices have FDA authorisation under the scalp-cooling product code PMC (21 CFR 878.4360), whose special controls require labelling on the potential risk of scalp metastasis: DigniCap by De Novo in December 2015 (DEN150010), the Paxman Scalp Cooler in April 2017 (K163484) on the SCALP trial, both extended to solid tumours in 2017 and 2018, DigniCap Delta in 2019, Cooler Heads' portable Amma in 2021 and Stemtech's Eva in November 2025. Dignitana became part of the Paxman Group in June 2025. Manual frozen caps predate them and hold no clearance. Shorter post-infusion cooling (20 minutes as effective as 45 or 90 with weekly paclitaxel; under 85 minutes sufficient in a 4,680-patient registry) and portable coolers both shorten chair time. Limb cryocompression applies the same idea to neuropathy, with mixed randomised results and a SWOG phase 3 trial running. The chair itself is a low-risk regulated device on which OnCo found no oncology study of comfort or pressure injury.

## Fields

- Kind: Roadmap
- Last checked: 2026-11-04
- Tags: machines-wave3

## Sources

- 21 CFR 878.4360, scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia (eCFR): https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-878/subpart-E/section-878.4360
- FDA De Novo DEN150010: DigniCap System (8 December 2015): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN150010
- FDA 510(k) K163484: Paxman Scalp Cooler (17 April 2017): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K163484
- FDA 510(k) K170871: DigniCap, solid tumours (3 July 2017): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170871
- FDA 510(k) K173032: Paxman, solid tumours (7 June 2018): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173032
- FDA 510(k) K191166: DigniCap Delta (26 June 2019): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191166
- FDA 510(k) K211526: Cooler Heads portable system (21 October 2021): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211526
- FDA 510(k) K252289: Eva Scalp Cooling System (25 November 2025): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252289
- Dignitana, part of the Paxman Group from 1 June 2025: https://dignitana.com/
- Lugtenberg et al., 20 versus 45 minutes of post-infusion scalp cooling with weekly paclitaxel, randomised trial (Support Care Cancer 2022): https://doi.org/10.1007/s00520-022-07090-7
- Breed et al., post-infusion cooling time in 4,680 patients, Dutch Scalp Cooling Registry (Support Care Cancer 2025): https://doi.org/10.1007/s00520-025-09526-2
- Kaufman et al., duration of scalp cooling and how it fits the infusion day: a review (Support Care Cancer 2025): https://doi.org/10.1007/s00520-025-10058-y
- Weaver et al., Penguin cold caps in 100 patients at one institution (Support Care Cancer 2024): https://doi.org/10.1007/s00520-024-08393-7
- Paxman: the Paxman Neuropathy System (limb cryocompression): https://paxmangroup.com/reduce-nerve-damage/paxman-neuropathy/
- Champion Healthcare Solutions: oncology and infusion medical recliners: https://championchair.com/clinical-applications/oncology-infusion-chairs/
- Slayton et al., pressure mapping of a standard hospital recliner in 34 healthy adults (J Wound Ostomy Continence Nurs 2017): https://doi.org/10.1097/won.0000000000000300

## Connected records

- roadmaps: [Devices and physical therapies roadmap: heat and light → electric fields and focused sound → drug-releasing implants](https://onco.cc/roadmaps/devices-roadmap/)
- ideas: [A prevention programme for chemotherapy nerve damage: SARM1 inhibitors, cooling and compression](https://onco.cc/ideas/idea-moon-neuropathy-prevention-programme/), [Choose cold or compression for neuropathy by what patients can keep on](https://onco.cc/ideas/idea-mach-cold-or-compression-by-adherence/), [Finish scalp cooling away from the infusion chair](https://onco.cc/ideas/idea-mach-cooling-off-the-chair/), [Fund scalp cooling and hair-preserving measures for every alopecia-inducing regimen](https://onco.cc/ideas/idea-moon-hair-preservation-for-all/), [Measure skin pressure and comfort in oncology infusion chairs](https://onco.cc/ideas/idea-mach-infusion-chair-pressure-study/)
- fronts: [Chemotherapy](https://onco.cc/fronts/chemotherapy/), [Devices & Physical Therapies](https://onco.cc/fronts/devices/), [Supportive Care & Survivorship](https://onco.cc/fronts/supportive-care/)
- technologies: [Frozen gloves, socks and compression for taxane nail and nerve damage](https://onco.cc/technologies/frozen-gloves-compression-taxane/), [Infusion pumps, ports, and ambulatory chemotherapy devices](https://onco.cc/technologies/infusion-devices-vascular-access/), [Limb cryocompression devices for chemotherapy nerve damage (Paxman Neuropathy System, Hilotherm ChemoCare)](https://onco.cc/technologies/limb-cryocompression-devices/), [Manual cold caps (Penguin and other frozen-gel caps)](https://onco.cc/technologies/manual-cold-caps/), [Oncology infusion and treatment chairs](https://onco.cc/technologies/oncology-infusion-chairs/), [Oral cryotherapy (ice chips) to prevent mucositis](https://onco.cc/technologies/oral-cryotherapy-mucositis/), [Scalp cooling (cold caps: DigniCap, Paxman)](https://onco.cc/technologies/scalp-cooling/)
- companies: [Cooler Heads Care](https://onco.cc/companies/cooler-heads-care/), [Dignitana](https://onco.cc/companies/dignitana/), [Hilotherm](https://onco.cc/companies/hilotherm/), [Paxman](https://onco.cc/companies/paxman/), [Stemtech Medical Devices](https://onco.cc/companies/stemtech-medical-devices/)
- trials: [CONTRoL (cryotherapy against compression for neuropathy)](https://onco.cc/trials/control-cipn-trial/), [DigniCap pivotal cohort study](https://onco.cc/trials/dignicap-cohort-trial/), [Duke cryocompression trial in gynaecological cancer](https://onco.cc/trials/duke-cryocompression-gyn/), [ICE COMPRESS (SWOG, cooling or compression of limbs to prevent neuropathy)](https://onco.cc/trials/ice-compress-swog/), [SCALP randomised trial of the Paxman cooler](https://onco.cc/trials/scalp-trial/)
- bottlenecks: [Survivorship and late effects are neglected](https://onco.cc/bottlenecks/b-survivorship/), [Toxicity and quality of life are undervalued](https://onco.cc/bottlenecks/b-toxicity-qol/)

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