FREEDOM BATH— 510(k) K952442

Substantially Equivalent

Grand Traverse Technologies

FDA 510(k) clearance K952442 for FREEDOM BATH, Substantially Equivalent on 1995-11-02. Applicant: Grand Traverse Technologies.

Clearance details

Applicant
Grand Traverse Technologies
Product code
Code ILJ
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Traverse City, MI, 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.