MOMENTUM NO. FS008 WHEELCHAIR— 510(k) K982099

Substantially Equivalent

Sriram Enterprises D.B.A. Momentum Group

FDA 510(k) clearance K982099 for MOMENTUM NO. FS008 WHEELCHAIR, Substantially Equivalent on 1998-10-05. Applicant: Sriram Enterprises D.B.A. Momentum Group.

Clearance details

Applicant: Sriram Enterprises D.B.A. Momentum Group
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 1998-06-15
Decision date: 1998-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, 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.