COOLER HEADS CARE, INC.

FDA Device Registration & Listing · San Diego, CA, US · Registration 3021619527

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3021619527
FEI Number
3021619527
Entity Name
COOLER HEADS CARE, INC.
City/State/Country
San Diego, CA, US
Establishment Address
610 Gateway Center Way, Ste G, San Diego, CA 92102, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Cooler Heads Care, Inc. (Owner Number: 10084301)
Owner / Operator Contact Address
610 Gateway Center Way, Ste G, San Diego, CA 92102, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K211526
PMA Number
N/A

All Registered Proprietary Names

AMMA

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PMC Scalp Cooling System General, Plastic Surgery Class 2 878.4360 2022-02-07

Official Correspondent

Kate Dilligan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cooler Heads Care, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021619527. Last updated year: 2026. Please use registration number 3021619527 when referencing this establishment in official correspondence.
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