ALPHA PUSH KART— 510(k) K841911

Name: FDA 510(k) clearance K841911
Creator: U.S. Food and Drug Administration
Published: 1984-05-23

Substantially Equivalent

Alpha Unlimited, Inc.

FDA 510(k) clearance K841911 for ALPHA PUSH KART, Substantially Equivalent on 1984-05-23. Applicant: Alpha Unlimited, Inc.. Device class: 1.

Clearance details

Applicant: Alpha Unlimited, Inc.
Product code: Code INM
Device class: Class 1
Regulation: 21 CFR 890.3100
Advisory panel: Physical Medicine
Date received: 1984-05-09
Decision date: 1984-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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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.