EBI OMEGA 21 SYSTEM— 510(k) K990303

Substantially Equivalent

Electro-Biology, Inc.

FDA 510(k) clearance K990303 for EBI OMEGA 21 SYSTEM, Substantially Equivalent on 1999-04-29. Applicant: Electro-Biology, Inc..

Clearance details

Applicant: Electro-Biology, Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1999-02-01
Decision date: 1999-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

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Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.