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510(k) Data Aggregation
K Number
K150349Device Name
Rapid Hair Removal Pads
Manufacturer
FULL POWER AED
Date Cleared
2015-07-14
(153 days)
Product Code
LDD
Regulation Number
870.5300Why did this record match?
Applicant Name (Manufacturer) :
FULL POWER AED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To remove excessive hair prior to placement of defibrillator electrodes.
Device Description
The Rapid Hair Removal Pads ("RHRP") are intended to be used by medical professionals prior to the placement of DC-Defibrillator, Low Energy electrodes to remove excessive chest and side torso hair from a victim of sudden cardiac arrest. This hair can significantly impede the defibrillator's performance in analyzing the heart's rhythm and delivering an appropriate shock. The primary mechanism of the RHRP is a high-tack adhesive that removes hair from the sites on the chest and side torso on which these electrodes are to be placed, prepping the site for optimal electrode-to-skin contact. RHRP is a single-use product and can be disposed of with other emergency single-use equipment.
To use the RHRP, the user removes the pads from the outer packaging, peels the pads sequentially off the non-stick PET liner backing, and places the adhesive side of the pad at two sites—on the chest and side torso-where the defibrillator electrodes will be placed. The user presses the pads on firmly to adhere them to the hair and skin at those sites. The user then pulls the pads quickly away from the skin in the opposite direction of hair growth. The resulting area is left substantially cleared of hair, decreasing impedance and increasing electrode-to-skin contact.
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