WALK N ROLL— 510(k) K830784

Substantially Equivalent

Meta-Morris

FDA 510(k) clearance K830784 for WALK N ROLL, Substantially Equivalent on 1983-05-25. Applicant: Meta-Morris.

Clearance details

Applicant
Meta-Morris
Product code
Code ITJ
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code ITJ

product code ITJ
Death
8
Injury
571
Other
2
Total
581

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.