FDA 510(k)

RW-1

K-Number: K253029 · 2026-03-31

Decision Date2026-03-31

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

RW-1 is the device name listed in this FDA 510(k) record. The listed applicant is Mediott, Inc.. It received FDA 510(k) clearance on 2026-03-31 under 510(k) 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. The listed applicant is Mediott, Inc.. The 510(k) number is K253029.

When did RW-1 receive FDA 510(k) clearance?

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

Who is the listed applicant for RW-1?

The FDA 510(k) record lists Mediott, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RW-1?

The FDA product code for RW-1 is LLZ.

Other records listing Mediott, Inc. as applicant

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.

K232456RW-1

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.