MANUAL WHEELCHAIR— 510(k) K982607

Substantially Equivalent

G. Hirsch and Co., Inc.

FDA 510(k) clearance K982607 for MANUAL WHEELCHAIR, Substantially Equivalent on 1998-08-31. Applicant: G. Hirsch and Co., Inc..

Clearance details

Applicant: G. Hirsch and Co., Inc.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 1998-07-27
Decision date: 1998-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlingame, CA, 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.