MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651— 510(k) K001252

Substantially Equivalent

Maxhealth Corp.

FDA 510(k) clearance K001252 for MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651, Substantially Equivalent on 2000-06-12. Applicant: Maxhealth Corp..

Clearance details

Applicant: Maxhealth Corp.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2000-04-19
Decision date: 2000-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

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.