PACE SAVER LITTLE JUNIOR (MODIFICATION)— 510(k) K954974

Substantially Equivalent

Burke Mobility Products

FDA 510(k) clearance K954974 for PACE SAVER LITTLE JUNIOR (MODIFICATION), Substantially Equivalent on 1996-03-19. Applicant: Burke Mobility Products.

Clearance details

Applicant: Burke Mobility Products
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 1995-10-25
Decision date: 1996-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mission, KS, US

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Adverse events under product code INI

product code INI

Injury: 171
Other: 1
Total: 172

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.