A.L.A.R.M. (ADJUST. LEG & ANKLE REPOSITIONING MECH— 510(k) K872525

Name: FDA 510(k) clearance K872525
Creator: U.S. Food and Drug Administration
Published: 1988-02-22

Substantially Equivalent

M.C. Johnson Co., Inc.

FDA 510(k) clearance K872525 for A.L.A.R.M. (ADJUST. LEG & ANKLE REPOSITIONING MECH, Substantially Equivalent on 1988-02-22. Applicant: M.C. Johnson Co., Inc.. Device class: 2.

Clearance details

Applicant: M.C. Johnson Co., Inc.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 1987-06-25
Decision date: 1988-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leominster, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.