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)

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.