Aksys Ltd.

Recipient:Aksys Ltd..
Product:Aksys PHD Personal Hemodialysis System
Date: 6/806

Our records do not show that you obtained marketing clearance or approval before you began offering your device for sale with a modified treatment length. The device was cleared via a premarket notification (510(k)) _____, on _____, with a specified treatment length of _____ using a _____. Your current website indicates a modified treatment length of _____ using a _____. Such a change would require significant modifications to the design and software of the device, and could affect the safety due to _____ and/or _____ quality issues. FDA will evaluate this information and decide whether your product may be legally marketed.

Issuer: Center for Devices and Radiological Health (CDRH)

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Partners located in the US (CA, FL, MA, MN, TN) and Italy.