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Is the T-Scan III system in accordance with the FDA?

April 26, 2017accordance fda III system T-scan

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Is the T-Scan III system in accordance with the FDA?

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Tekscan systems are considered Class I devices by the FDA and are exempt from pre-market notification (501K) because of their low-risk profiles since they are not life-supporting or life-sustaining nor of substantial importance in preventing impairment of health nor present a potential unreasonable risk of illness or injury.