DURABLE MEDICAL EQUIPMENT COMPANY, STANDARD MECHANICAL WHEELCHAIR— 510(k) K934297

Substantially Equivalent

Durable Medical Equipment, Inc.

FDA 510(k) clearance K934297 for DURABLE MEDICAL EQUIPMENT COMPANY, STANDARD MECHANICAL WHEELCHAIR, Substantially Equivalent on 1993-11-01. Applicant: Durable Medical Equipment, Inc..

Clearance details

Applicant: Durable Medical Equipment, Inc.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 1993-09-02
Decision date: 1993-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsboro, NC, 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.