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FDA 510(k)

Portable Scalp Cooling System

K-Number: K211526 · 2021-10-21

ApplicantCooler Heads Care, Inc.
Decision Date2021-10-21
Product CodePMC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Portable Scalp Cooling System is a medical device manufactured by Cooler Heads Care, Inc.. It received FDA 510(k) clearance on 2021-10-21 under approval number K211526. The device is classified under product code PMC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Portable Scalp Cooling System?

Portable Scalp Cooling System is a medical device that received FDA 510(k) clearance on 2021-10-21. It is manufactured by Cooler Heads Care, Inc.. The 510(k) number is K211526.

When was Portable Scalp Cooling System approved by the FDA?

Portable Scalp Cooling System received FDA 510(k) clearance on 2021-10-21, under approval number K211526.

What company makes Portable Scalp Cooling System?

Portable Scalp Cooling System is manufactured by Cooler Heads Care, Inc..

What is the FDA product code for Portable Scalp Cooling System?

The FDA product code for Portable Scalp Cooling System is PMC.

Related Clinical Trials

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Related PubMed Literature

PMID: 41269388 Adverse effects of scalp cooling for the reduction of chemotherapy-induced alopecia: A systematic review and meta-analysis. Breast cancer research and treatment (2025)

Related Devices (Code: PMC)

K170871DigniCap Scalp Cooling SystemDignitana AB K163484Paxman Scalp CoolerPaxman Coolers Limited K173032Paxman Scalp CoolerPaxman Coolers Limited K191166DigniCap DeltaDignitana, Inc. K252289Eva Scalp Cooling SystemStemtech Medical Devices Private Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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