Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016555200

FEI Number

3016555200

Entity Name

XENA COOL LLC

City/State/Country

Red Wing, MN, US

Establishment Address

957 Tile Drive, Red Wing, MN 55066, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

XENA VENTURES LLC (Owner Number: 10062560)

Owner / Operator Contact Address

145 Maple Hill Rd, Hopkins, MN 55343, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ONYX COOL Knee - SkinSafe 58 Opal Cool Crown - SkinSafe 58 Opal Cool Shoulder/Foot+ - Skin Safe 58 Opal Cool Eye Need to Chill - SkinSafe 58 ONYX COOL VEST - CoolNow 80 Opal Cool Gal Pals Chill - SkinSafe 58 Opal Cool Pad - CoolNow 80 ONYX COOL Shoulder/Foot+ - SkinSafe 58 Opal Cool Hot Flash Cape - SkinSafe 58 ONYX COOL Chill Minis - SkinSafe 58 Opal Cool Wrap - CoolNow 80 Opal Cool Eye Mask - SkinSafe 58 ONYX COOL PAD - CoolNow 80 ONYX COOL VEST - SkinSafe 58 Opal Cool Wrap - SkinSafe 58 Opal Cool Breast Friends - SkinSafe 58 Opal Cool Got You Covered - SkinSafe 58 Opal Cool Gal Pals Go - CoolNow 80 ONYX COOL Back/Hip - SkinSafe 58 ONYX COOL Go Minis - CoolNow 80 Opal Cool Cap - SkinSafe58 ONYX COOL CAP - SkinSafe 58 Opal Cool Breast Friends - CoolNow 80 ONYX COOL Back/Hip - Cool Now 80 ONYX COOL CAP - CoolNow 80 Opal Cool One - SkinSafe58 Opal Cool Dreams - CoolNow 80

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	2020-02-13

Official Correspondent

Tammy Lee

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

XENA VENTURES LLC

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 3016555200. Last updated year: 2026. Please use registration number 3016555200 when referencing this establishment in official correspondence.