FDA Compliance
How does the new FDA performance standard for patient lead cords affect me?
Complying with the new FDA performance standard can increase reimbursement and patient confidence—while decreasing costly down time and liability risks.
Provide a safe, risk-free environment for you and your patient.
•We can upgrade your stimulation modalities to certify compliance with 21 CFR 898.
•We also provide ultrasound calibration service and patient area safety analysis.
•Some periodic maintenance is required by the manufacturer to maintain extended warranty coverage (Zenith® Service Alert, etc.)
•Service is performed by qualified manufacturer’s service representative and certified electronics technicians.
•Affordable installation rates—product upgrade prices vary by manufacturer.