Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002393819

FEI Number

3002393819

Entity Name

MEDICAL SPECIALTIES OF CALIFORNIA LIMITED

City/State/Country

Orpington Kent, GB

Establishment Address

161A-163A High Street, Orpington Kent BR6 0LW, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Medical Specialties of California Limited (Owner Number: 10052691)

Owner / Operator Contact Address

161A-163A High Street, Orpington, GB-KEN BR6 0LW, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Penguin Cold Cap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2016-09-14

Official Correspondent

Frank Fronda

US Agent Details

Geralyn Pewarchie Email: geralynpewarchie@penguincoldcaps.com Phone: (810) 8416613

Related Public Records

Same Entity

Medical Specialties of California Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002393819. Last updated year: 2026. Please use registration number 3002393819 when referencing this establishment in official correspondence.