DeviceClearance

FREERIDER, MODEL FR510-F— 510(k) K971387

Substantially Equivalent

Freerider USA, Inc.

FDA 510(k) clearance K971387 for FREERIDER, MODEL FR510-F, Substantially Equivalent on 1997-07-23. Applicant: Freerider USA, Inc.. Device class: 2.

Clearance details

Applicant
Freerider USA, Inc.
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
Eugene, OR, US
Download summary PDFView on FDA.gov ↗

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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.