RX-1 Sleep
K-Number: K253148 · 2026-06-22
Device Summary
Frequently Asked Questions
What is the RX-1 Sleep?
RX-1 Sleep is a medical device that received FDA 510(k) clearance on 2026-06-22. The listed applicant is Vivaquant, Inc. Dba Rhythm Express. The 510(k) number is K253148.
When did RX-1 Sleep receive FDA 510(k) clearance?
RX-1 Sleep received FDA 510(k) clearance on 2026-06-22, under 510(k) number K253148.
Who is the listed applicant for RX-1 Sleep?
The FDA 510(k) record lists Vivaquant, Inc. Dba Rhythm Express as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RX-1 Sleep?
The FDA product code for RX-1 Sleep is MNR.
Related Devices (Code: MNR)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.