PERMOBIL POWERED WHEELCHAIR 1280— 510(k) K991658

Substantially Equivalent

Permobil AB

FDA 510(k) clearance K991658 for PERMOBIL POWERED WHEELCHAIR 1280, Substantially Equivalent on 1999-10-08. Applicant: Permobil AB.

Clearance details

Applicant: Permobil AB
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 1999-05-14
Decision date: 1999-10-08
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Sollentuna, SE

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.