VIBRO BATH MODEL FS-1— 510(k) K771966

Name: FDA 510(k) clearance K771966
Creator: U.S. Food and Drug Administration
Published: 1977-11-02

Substantially Equivalent

Dazey Products Co.

FDA 510(k) clearance K771966 for VIBRO BATH MODEL FS-1, Substantially Equivalent on 1977-11-02. Applicant: Dazey Products Co.. Device class: 2.

Clearance details

Applicant: Dazey Products Co.
Product code: Code ILJ
Device class: Class 2
Regulation: 21 CFR 890.5100
Advisory panel: Physical Medicine
Date received: 1977-10-17
Decision date: 1977-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K771968 — WHIRLPOOL BATH MODEL 22731977-10-28
K771971 — HYDROMASSAGE EQUIP. MODEL 10001977-10-21

Adverse events under product code ILJ

product code ILJ

Death: 4
Total: 4

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.