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510(k) K150349

Rapid Hair Removal Pads by Full Power Aed — Product Code LDD

K150349 is an FDA 510(k) premarket notification submitted by Full Power Aed for the device "Rapid Hair Removal Pads". The FDA issued a decision of Substantially Equivalent on July 14, 2015. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2015
Date Received
February 11, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Device Class
Class II
Regulation Number
870.5300
Review Panel
CV
Submission Type

Other clearances for product code LDD

  • K203231 — Switched Internal Paddles (January 11, 2021)
  • K200849 — Tempus LS - Manual (July 24, 2020)
  • K182503 — Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators (June 3, 2019)
  • K140502 — ZOLL E SERIES ALS (November 6, 2014)
  • K103651 — CARDIOMED (October 4, 2011)
  • K103783 — EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDI (June 16, 2011)
  • K103334 — CARDIO MED (January 18, 2011)
  • K103159 — CARDIO MED MODEL A102, H104, O101, P103, AND Z100 (January 11, 2011)
  • K102468 — ZOLL PROPAQ MD (September 30, 2010)
  • K100654 — ZOLL PROPAQ MD (July 29, 2010)

FDA data resources