PACE SAVER LITTLE JR— 510(k) K925122

Name: FDA 510(k) clearance K925122
Creator: U.S. Food and Drug Administration
Published: 1994-03-30

Substantially Equivalent for Some Indications

Burke Mobility Products

FDA 510(k) clearance K925122 for PACE SAVER LITTLE JR, Substantially Equivalent for Some Indications on 1994-03-30. Applicant: Burke Mobility Products. Device class: 2.

Clearance details

Applicant: Burke Mobility Products
Product code: Code INI
Device class: Class 2
Regulation: 21 CFR 890.3800
Advisory panel: Physical Medicine
Date received: 1992-10-09
Decision date: 1994-03-30
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Mission, KS, US

Download summary PDF View on FDA.gov ↗

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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.