# K201935: Air Pressure Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Xiamen Weiyou Intelligent Technology Co., Ltd.
- Decided: Jun 22, 2021 after 344 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: 7 generations back to K850316 (1985). 18 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160608: NormaTec Pulse and NormaTec Pulse Pro, NormaTec Industries, LP (2016) Summary page 4.

## Most influential descendants
- K212935: Air Pressure Foot Massager (2022), 3 descendants of its own
- K222991: Air Compression Leg Massager (model: EMK-701) (2023), 2 descendants of its own
- K250046: Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) (2025), 0 descendants of its own
- K242140: Air Compression Leg Massager (K-705) (2025), 0 descendants of its own

## Indications for use
Air Pressure Therapy System VU-IPCO04B is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

Source page: https://510kreport.com/device/K201935
Methodology: https://510kreport.com/methodology