# K250916: WinForth (LM-E470KA)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Leaflife Technology Co., Ltd.
- Decided: Aug 14, 2025 after 140 days
- Product code: PBX (Massager, Vacuum, Radio Frequency Induced Heat)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The WinForth is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The WinForth massage device is intended to provide a temporary reduction in the appearance of cellulite.

Source page: https://510kreport.com/device/K250916
Methodology: https://510kreport.com/methodology