510(k) K070467
K070467 is an FDA 510(k) premarket notification submitted by Polar Wrap, LLC for the device "HEALTH MASK". The FDA issued a decision of Substantially Equivalent on April 17, 2007. The device falls under product code OBN (Humidifier, Respiratory, Mask (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2007
- Date Received
- February 16, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Humidifier, Respiratory, Mask (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5450
- Review Panel
- AN
- Submission Type
Intended to moderate blood pressure in hypertensive patients when they are exposed to the cold. The mask attenuates (moderates) the physiological response, increases in blood pressure, associated with cold exposure, by warming the inhaled air during cold exposure for individuals with hypertension, medicated or non-medicated.