TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0— 510(k) K993406

Substantially Equivalent

Permobil AB

FDA 510(k) clearance K993406 for TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0, Substantially Equivalent on 2000-12-18. Applicant: Permobil AB.

Clearance details

Applicant: Permobil AB
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 1999-10-08
Decision date: 2000-12-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Sollentuna, SE

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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.