WATER FLOATION BED 800/TC/H— 510(k) K840881

Name: FDA 510(k) clearance K840881
Creator: U.S. Food and Drug Administration
Published: 1984-07-18

Substantially Equivalent

Western Medical, Ltd.

FDA 510(k) clearance K840881 for WATER FLOATION BED 800/TC/H, Substantially Equivalent on 1984-07-18. Applicant: Western Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Western Medical, Ltd.
Product code: Code IOQ
Device class: Class 2
Regulation: 21 CFR 890.5170
Advisory panel: Physical Medicine
Date received: 1984-02-27
Decision date: 1984-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K894387 — WESTCO MADAYAG PAB NEEDLE1989-11-07
K891459 — STERILE BURNNET PRE-CUT (VARIOUS SIZES)1989-05-26
K840882 — HOME CARE WATER FLOTATION BED HC4/TC/H1984-07-18

Adverse events under product code IOQ

product code IOQ

Malfunction: 676
Other: 5
Total: 681

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.