Loading
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.
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.
Shares Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs, Scalp cooling (cold caps: DigniCap, Paxman) and the tag machines-wave3.
Shares Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs, Scalp cooling (cold caps: DigniCap, Paxman) and the tag machines-wave3.
Shares Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs, Scalp cooling (cold caps: DigniCap, Paxman) and the tag machines-wave3.
Shares Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs and the tag machines-wave3.
Shares Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs and the tag machines-wave3.
Shares Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs, Scalp cooling (cold caps: DigniCap, Paxman) and the tag machines-wave3.
Shares Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs, Scalp cooling (cold caps: DigniCap, Paxman) and the tag machines-wave3.
Shares Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs and the tag machines-wave3.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/