WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS— 510(k) K991275

Substantially Equivalent

Mckinley, Inc.

FDA 510(k) clearance K991275 for WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS, Substantially Equivalent on 1999-07-01. Applicant: Mckinley, Inc..

Clearance details

Applicant: Mckinley, Inc.
Product code: Code FRN
Advisory panel: General Hospital
Date received: 1999-04-14
Decision date: 1999-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheat Ridge, CO, US

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Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

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.