# K201645: Massage Compression Boots

- Pathway: 510(k) (Traditional)
- Applicant: Jkh USA, LLC
- Decided: Sep 15, 2020 after 90 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: 9 generations back to K850316 (1985). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122112: 2004-OC Massage System, 2008-OC Massage System, Bio Compression Systems, Inc. (2013) Summary page 4.
- K191862: Compression Therapy Device Model LGT-2200SP, Guangzhou Longest Science & Technology Co., Ltd. (2019) Summary page 4.

## Indications for use
The Massage Compression Boots are intended for the temporary relief of minor muscle aches and/or pains, and for the temporary increase in circulation to the treated areas. The device can simulate kneading and stroking of tissues by using an inflatable garment.

Source page: https://510kreport.com/device/K201645
Methodology: https://510kreport.com/methodology