# K192358: Pressure Therapy System PT1003

- Pathway: 510(k) (Traditional)
- Applicant: Xiamen Senyang Co., Ltd.
- Decided: Apr 23, 2020 after 238 days
- Product code: IRP (Massager, Powered Inflatable Tube)
- Device class: 2
- Regulation: 21 CFR 890.5650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K850316 (1985). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183169: Pulse 2.0, Pulse Pro 2.0, NormaTec Industries, LP (2018) Summary page 4.
- K182668: Rapid Reboot Compression Therapy System, Rapid Reboot Recovery Products, LLC (2018) Summary page 4.

## Recalls of this device
- Mar 7, 2023 · Class II · Z-1398-2023: Error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT). Marketed without a 510k for this indication

## Indications for use
The device is air pressure massager 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/K192358
Methodology: https://510kreport.com/methodology