DeviceClearance

FYMCO FLYER— 510(k) K915416

Substantially Equivalent

Motion Dynamics

FDA 510(k) clearance K915416 for FYMCO FLYER, Substantially Equivalent on 1992-08-03. Applicant: Motion Dynamics. Device class: 2.

Clearance details

Applicant
Motion Dynamics
Product code
Code INI
Device class
Class 2
Regulation
21 CFR 890.3800
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Concord, Ontario Canada, CA
Download summary PDFView on FDA.gov ↗

Recent devices under product code INI

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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.