Rapid Hair Removal Pads— 510(k) K150349

Substantially Equivalent

Full Power Aed

FDA 510(k) clearance K150349 for Rapid Hair Removal Pads, Substantially Equivalent on 2015-07-14. Applicant: Full Power Aed.

Clearance details

Applicant: Full Power Aed
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 2015-02-11
Decision date: 2015-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.