AQUASSAGER WM110/W210 & WM120 BODY BASICS MASSAGER— 510(k) K925907

Name: FDA 510(k) clearance K925907
Creator: U.S. Food and Drug Administration
Published: 1994-03-30

Substantially Equivalent

Pollenex Corp.

FDA 510(k) clearance K925907 for AQUASSAGER WM110/W210 & WM120 BODY BASICS MASSAGER, Substantially Equivalent on 1994-03-30. Applicant: Pollenex Corp.. Device class: 1.

Clearance details

Applicant: Pollenex Corp.
Product code: Code ISA
Device class: Class 1
Regulation: 21 CFR 890.5660
Advisory panel: Physical Medicine
Date received: 1992-11-20
Decision date: 1994-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ISA

product code ISA

Death: 3
Other: 1
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.