# Stemtech Medical Devices

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

## TL;DR

Stemtech Medical Devices of Navi Mumbai makes the Eva scalp cooling system, the most recent machine cleared by the FDA to reduce chemotherapy hair loss.

## Summary

Stemtech Medical Devices, Navi Mumbai, received 510(k) K252289 on 25 November 2025 for the Eva Scalp Cooling System, for patients with solid tumours, with DigniCap Delta as predicate; the summary states that "no clinical data was necessary to determine the substantial equivalence of this device". It is the seventh authorisation under the FDA scalp-cooling product code.

## Fields

- Kind: Company
- Last checked: 2026-11-04
- Also known as: Eva Scalp Cooling System
- Tags: machines-wave3
- HQ: Navi Mumbai
- Type: devices

## Sources

- FDA 510(k) K252289: Eva Scalp Cooling System (25 November 2025): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252289

## 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/)

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