RANGEROLLER (MODIFIED)— 510(k) K920325

Substantially Equivalent

Excel Mobility Products, Inc.

FDA 510(k) clearance K920325 for RANGEROLLER (MODIFIED), Substantially Equivalent on 1992-03-06. Applicant: Excel Mobility Products, Inc..

Clearance details

Applicant
Excel Mobility Products, Inc.
Product code
Code ITI
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Washington, DC, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code ITI

product code ITI
Death
34
Injury
778
Malfunction
1,085
Other
1
Total
1,898

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.