TANDA RESTORE, MODEL PTSCS— 510(k) K090008

Substantially Equivalent

Pharos Life Corporation

FDA 510(k) clearance K090008 for TANDA RESTORE, MODEL PTSCS, Substantially Equivalent on 2009-10-15. Applicant: Pharos Life Corporation.

Clearance details

Applicant: Pharos Life Corporation
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2009-01-02
Decision date: 2009-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

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.