RUG BUG WHEEL CHAIR— 510(k) K890490

Substantially Equivalent

Sinties Scientific, Inc.

FDA 510(k) clearance K890490 for RUG BUG WHEEL CHAIR, Substantially Equivalent on 1989-02-27. Applicant: Sinties Scientific, Inc..

Clearance details

Applicant: Sinties Scientific, Inc.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 1989-01-31
Decision date: 1989-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tulsa, OK, US

Download summary PDF View 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, 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.