SPECTRUM SMALL FRY— 510(k) K983859

Substantially Equivalent

Freedom Designs, Inc.

FDA 510(k) clearance K983859 for SPECTRUM SMALL FRY, Substantially Equivalent on 1998-11-25. Applicant: Freedom Designs, Inc..

Clearance details

Applicant: Freedom Designs, Inc.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 1998-10-26
Decision date: 1998-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Simi Valley, CA, US

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Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

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.