510(k) K915729— AUQASOOTHE/AQUA MED

Substantially Equivalent

Aquasoothe

Clearance details

Applicant: Aquasoothe
Product code: Code ISA
Advisory panel: Physical Medicine
Date received: 1991-12-20
Decision date: 1992-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kannapolis, NC, US

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.