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FDA 510(k)

RW-1

K-Number: K253029 · 2026-03-31

ApplicantMediott, Inc.
Decision Date2026-03-31
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RW-1 is a medical device manufactured by Mediott, Inc.. It received FDA 510(k) clearance on 2026-03-31 under approval number K253029. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RW-1?

RW-1 is a medical device that received FDA 510(k) clearance on 2026-03-31. It is manufactured by Mediott, Inc.. The 510(k) number is K253029.

When was RW-1 approved by the FDA?

RW-1 received FDA 510(k) clearance on 2026-03-31, under approval number K253029.

What company makes RW-1?

RW-1 is manufactured by Mediott, Inc..

What is the FDA product code for RW-1?

The FDA product code for RW-1 is LLZ.

Other Devices by Mediott, Inc.

K232456RW-1

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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.

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