K-number	K250916
Device name	WinForth (LM-E470KA)
Applicant	Shenzhen Leaflife Technology Co., Ltd.
Product code	PBX
Device class	Class II
Decision date	Aug 14, 2025
Decision	Substantially Equivalent
Regulation	878.4400

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The WinForth (LM-E470KA) is an electrosurgical cutting and coagulation device intended to provide topical heating for treating selected medical conditions such as pain relief, muscle spasms, and increased local circulation. It is also marketed as a massage device intended to temporarily reduce the appearance of cellulite.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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WinForth (LM-E470KA)

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