CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC MONACO, I, II, III & CLASSIC— 510(k) K022387

Name: FDA 510(k) clearance K022387
Creator: U.S. Food and Drug Administration
Published: 2002-09-19

Substantially Equivalent

Craftmatic Organization, Inc.

FDA 510(k) clearance K022387 for CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC MONACO, I, II, III & CLASSIC, Substantially Equivalent on 2002-09-19. Applicant: Craftmatic Organization, Inc.. Device class: 2.

Clearance details

Applicant: Craftmatic Organization, Inc.
Product code: Code LLI
Device class: Class 2
Regulation: 21 CFR 880.5100
Advisory panel: General Hospital
Date received: 2002-07-23
Decision date: 2002-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Recent devices under product code LLI

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K840787 — CRAFTMATIC ELECTRIC ADJUSTABLE BED1984-06-13

Adverse events under product code LLI

product code LLI

Death: 10
Total: 10

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.