Luggie Super— 510(k) K151944

Substantially Equivalent

Freerider Corporation

FDA 510(k) clearance K151944 for Luggie Super, Substantially Equivalent on 2015-09-10. Applicant: Freerider Corporation.

Clearance details

Applicant
Freerider Corporation
Product code
Code INI
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Kang-Shan Dist, TW
Download summary PDFView on FDA.gov ↗

Adverse events under product code INI

product code INI
Injury
171
Other
1
Total
172

Source: openFDA MAUDE database, through . 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.