DRAKE & DRAKE/200 DL— 510(k) K921467

Substantially Equivalent

Am Scooters

FDA 510(k) clearance K921467 for DRAKE & DRAKE/200 DL, Substantially Equivalent on 1992-04-29. Applicant: Am Scooters.

Clearance details

Applicant: Am Scooters
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 1992-03-27
Decision date: 1992-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sarasota, FL, 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.