# K250244: Compression Therapy Device (LGT-2210DS)

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Longest Medical Technology Co., Ltd.
- Decided: Jul 25, 2025 after 179 days
- Product code: IRP (Massager, Powered Inflatable Tube)
- Device class: 2
- Regulation: 21 CFR 890.5650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K914774 (1992). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112441: Compressible Limb and Circulation Therapy System, Daesung Maref Co., Ltd. (2012) Summary page 5.

## Indications for use
Compression Therapy Device (Model: LGT-2210DS) is intended for Prophylaxis and treatment of edema (Chronic venous edema, Lymphedema, Post-mastectomy lymphedema). Compression Therapy Device (Model: LGT-2210DS) is intended exclusively for use by medical specialists and is only allowed to be used by qualified and instructed medical persons in clinical and hospital. The compression Therapy Device (Model: LGT-2210DS) is designed to be used in patients over 22 years old.

Source page: https://510kreport.com/device/K250244
Methodology: https://510kreport.com/methodology