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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 a medical device manufactured by Shenzhen Leaflife Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-08-14 under approval 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. It is manufactured by Shenzhen Leaflife Technology Co., Ltd.. The 510(k) number is K250916.

When was WinForth (LM-E470KA) approved by the FDA?

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

What company makes WinForth (LM-E470KA)?

WinForth (LM-E470KA) is manufactured by Shenzhen Leaflife Technology Co., Ltd..

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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