Rapid Hair Removal Pads

Dc-defibrillator, Low-energy, (including Paddles)

FULL POWER AED

The following data is part of a premarket notification filed by Full Power Aed with the FDA for Rapid Hair Removal Pads.

Pre-market Notification Details

Device IDK150349
510k NumberK150349
Device Name:Rapid Hair Removal Pads
ClassificationDc-defibrillator, Low-energy, (including Paddles)
Applicant FULL POWER AED 707 East Hudson Ave Durham,  NC  27704
ContactJahn Power
CorrespondentJahn Power
FULL POWER AED 707 East Hudson Ave Durham,  NC  27704
Product CodeLDD  
CFR Regulation Number870.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-11
Decision Date2015-07-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00867855000308 K150349 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.