Cleared Traditional

Rapid Hair Removal Pads

K150349 · Full Power Aed · Cardiovascular

Jul 2015

Decision

153d

Days

Class 2

Risk

About This 510(k) Submission

K150349 is an FDA 510(k) clearance for the Rapid Hair Removal Pads, a Dc-defibrillator, Low-energy, (including Paddles) (Class II — Special Controls, product code LDD), submitted by Full Power Aed (Durham, US). The FDA issued a Cleared decision on July 14, 2015, 153 days after receiving the submission on February 11, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5300.

Submission Details

510(k) Number	K150349 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 2015
Decision Date	July 14, 2015
Days to Decision	153 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF