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

Name: FDA 510(k) clearance K001252
Creator: U.S. Food and Drug Administration
Published: 2000-06-12

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.. Device class: 1.

Clearance details

Applicant: Maxhealth Corp.
Product code: Code IOR
Device class: Class 1
Regulation: 21 CFR 890.3850
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 ↗

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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.