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FDA 510(k)

RW-1

K-Number: K232456 · 2025-08-11

ApplicantMediott, Inc.
Decision Date2025-08-11
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 2025-08-11 under approval number K232456. 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 2025-08-11. It is manufactured by Mediott, Inc.. The 510(k) number is K232456.

When was RW-1 approved by the FDA?

RW-1 received FDA 510(k) clearance on 2025-08-11, under approval number K232456.

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.

K253029RW-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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