Tablo, Solo Home Hemodialysis, FDA approval for or Clinical Trial

Is Tablo FDA approved for Solo Home HemoDialysis or have a Solo Home HemoDialysis Clinical Trial underway?

I was trained and approved for Home HemoDialysis on the NxStage machine, and have done 3 years of Solo on NxStage.

I am impressed by what I heard about Tablo. And would like to explore switching. However, my home dialysis center says Tablo is not FDA approved for Solo and will need me to have a partner.

I emailed OutSet. They have yet to respond.

Thank you for your help!!!
GeorgeSR

There is a March 31, 2020 letter from the FDA to Outset responding to its 510(k) application for permission to market the Tablo HD machine. The letter includes the following statement on the last page:
Indications for Use (Describe)
The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician’s prescription and observed by a trained individual who is considered competent in the use of the device. The Tablo Hemodialysis System is also indicated for use in the home.