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FDA 510(k)

WinForth (LM-E470KA)

K-Number: K250916 · 2025-08-14

ApplicantShenzhen Leaflife Technology Co., Ltd.
Decision Date2025-08-14
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WinForth (LM-E470KA) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Leaflife Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-08-14 under 510(k) number K250916. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WinForth (LM-E470KA)?

WinForth (LM-E470KA) is a medical device that received FDA 510(k) clearance on 2025-08-14. The listed applicant is Shenzhen Leaflife Technology Co., Ltd.. The 510(k) number is K250916.

When did WinForth (LM-E470KA) receive FDA 510(k) clearance?

WinForth (LM-E470KA) received FDA 510(k) clearance on 2025-08-14, under 510(k) number K250916.

Who is the listed applicant for WinForth (LM-E470KA)?

The FDA 510(k) record lists Shenzhen Leaflife Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WinForth (LM-E470KA)?

The FDA product code for WinForth (LM-E470KA) is PBX.

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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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