PENOX PERFORMER WHEELCHAIR— 510(k) K852109

Substantially Equivalent

Penox Technologies, Inc.

FDA 510(k) clearance K852109 for PENOX PERFORMER WHEELCHAIR, Substantially Equivalent on 1985-08-22. Applicant: Penox Technologies, Inc..

Clearance details

Applicant: Penox Technologies, Inc.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 1985-05-15
Decision date: 1985-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittston, PA, 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.