New FDA Compliance & Device Qualifications

Our mobile medical device meets rigorous standards for clinical use:

• FDA 510(k) Cleared Medical Device

• Class II Medical Device Classification

• Compliant with FDA Quality System Regulations (21 CFR Part 820)

• Manufactured in ISO 13485 certified facilities

• Biocompatibility tested per ISO 10993 standards

• Electrical safety certified to IEC 60601-1 standards

• EMC compliance per IEC 60601-1-2

• Clinical validation studies supporting efficacy claims

• Post-market surveillance and adverse event reporting systems in place

• Regular calibration and quality assurance protocols

• Comprehensive operator training and certification programs

• Full technical documentation and clinical support available