DISC-O-AID— 510(k) K821903

Name: FDA 510(k) clearance K821903
Creator: U.S. Food and Drug Administration
Published: 1982-07-20

Substantially Equivalent

M. Dahm International Aps

FDA 510(k) clearance K821903 for DISC-O-AID, Substantially Equivalent on 1982-07-20. Applicant: M. Dahm International Aps. Device class: 1.

Clearance details

Applicant: M. Dahm International Aps
Product code: Code IKX
Device class: Class 1
Regulation: 21 CFR 890.5050
Advisory panel: Physical Medicine
Date received: 1982-06-28
Decision date: 1982-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IKX

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K862895 — TRICYCLES1986-08-13
K842650 — WALL GRAB BARS 98130-981361984-08-10
K831541 — TUB TRANSFER BENCH BK64811983-06-02
K823639 — BOARD TO TRANSFER PARALYZED PATIENT FROM1983-01-21
K823640 — BATH TUB SAFETY BAR1983-01-21

Adverse events under product code IKX

product code IKX

Death: 11
Total: 11

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.