NISSIN PEDIATRIC SERIES WHEELCHAIR— 510(k) K063521

Substantially Equivalent

Nissin Medical, Inc.

FDA 510(k) clearance K063521 for NISSIN PEDIATRIC SERIES WHEELCHAIR, Substantially Equivalent on 2007-02-05. Applicant: Nissin Medical, Inc..

Clearance details

Applicant: Nissin Medical, Inc.
Product code: Code INM
Advisory panel: Physical Medicine
Date received: 2006-11-22
Decision date: 2007-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torrance, CA, US

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Adverse events under product code INM

product code INM

Death: 3
Total: 3

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.