RAPID-AID THERAPEUTIC/SCANNING ULTRASOUND GEL— 510(k) K963169

Substantially Equivalent

Rapid-Aid Ltd./Ltee

FDA 510(k) clearance K963169 for RAPID-AID THERAPEUTIC/SCANNING ULTRASOUND GEL, Substantially Equivalent on 1996-11-12. Applicant: Rapid-Aid Ltd./Ltee.

Clearance details

Applicant: Rapid-Aid Ltd./Ltee
Product code: Code ITX
Advisory panel: Radiology
Date received: 1996-08-14
Decision date: 1996-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississuaga,Ontario, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.