AUQASOOTHE/AQUA MED— 510(k) K915729

Name: FDA 510(k) clearance K915729
Creator: U.S. Food and Drug Administration
Published: 1992-04-29

Substantially Equivalent

Aquasoothe

FDA 510(k) clearance K915729 for AUQASOOTHE/AQUA MED, Substantially Equivalent on 1992-04-29. Applicant: Aquasoothe. Device class: 1.

Clearance details

Applicant: Aquasoothe
Product code: Code ISA
Device class: Class 1
Regulation: 21 CFR 890.5660
Advisory panel: Physical Medicine
Date received: 1991-12-20
Decision date: 1992-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kannapolis, NC, US

Download summary PDF View on FDA.gov ↗

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K210166 — Omnispec ED10002023-01-27
K213120 — OW100S (model OW100S-US)2022-10-12

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.