REM 250 THREE WHEELED ELECTRIC CART— 510(k) K881766

Substantially Equivalent

Royal Enterprises Manufacturing, Inc.

FDA 510(k) clearance K881766 for REM 250 THREE WHEELED ELECTRIC CART, Substantially Equivalent on 1988-05-17. Applicant: Royal Enterprises Manufacturing, Inc..

Clearance details

Applicant: Royal Enterprises Manufacturing, Inc.
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 1988-04-25
Decision date: 1988-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

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Adverse events under product code INI

product code INI

Injury: 171
Other: 1
Total: 172

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.