Search Results
Found 1 results
510(k) Data Aggregation
K Number
K070467Device Name
HEALTH MASK
Manufacturer
Date Cleared
2007-04-17
(60 days)
Product Code
Regulation Number
868.5450Why did this record match?
Applicant Name (Manufacturer) :
POLAR WRAP LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Health Mask is intended to moderate the expected physiological response to cold (i.e., increase in blood pressure). For diagnosed hypertensives 18 years or older.
Device Description
The Health mask is a device worn by an individual outdoors when the air is cold. It is designed to retain the heat and moisture exhaled by the wearer and warm and humidify the inhaled cold air. The wearer breathes through a thermal medium which retains and returns the heat and moisture in the breathed air. The Thermal medium is placed inside a fabric mask which the wearer places over their mouth and nose. The mask is held in place with an elastic band.
Ask a Question
Ask a specific question about this device
Page 1 of 1