OVERHEAD WHIRLPOOL HAND SPA BRAND— 510(k) K840282

Substantially Equivalent

Priest Enterprises, Inc.

FDA 510(k) clearance K840282 for OVERHEAD WHIRLPOOL HAND SPA BRAND, Substantially Equivalent on 1984-02-04. Applicant: Priest Enterprises, Inc..

Clearance details

Applicant
Priest Enterprises, Inc.
Product code
Code ILJ
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code ILJ

product code ILJ
Death
4
Total
4

Source: openFDA MAUDE database, through . 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.