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Pressure Therapy System

XIAMEN SENYANG CO.,LTD · Model PT1002 · UDI-DI 06952075702973

IRP Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

101

Facilities

Description

Indications for Use: The device is indicated for use by medical professionals and patient at home, who are under medical supervision, in treating many conditions, such as: Primary lymph edema, edema following trauma and sport injures, Post immobilization edema, Venous insufficiencies, Lymph edema. Device Description: The system consists of an air pump, leg sleeves and hoses working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; one sleeve has 4 compression chambers. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. This software is to control the timing and the pressure reflected by the sensor, it cycles the airflow to reach the function of cycling compression of body parts.

Recalls

Date	Firm	Reason
2025-01-17	Zhejiang Luyao Electronics Technology Co., Ltd.	Regulatory documentation error and misleading color packaging claim.
2023-03-07	Compass Health Brands (Corporate Office)	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 indica
2017-01-13	Won Industry Co.	Distribution of unapproved devices with incorrect air compression level setup
2017-01-13	Won Industry Co.	Distribution of unapproved devices with incorrect air compression level setup
2011-08-23	CoolSystems, Inc.	It was discovered that some Game Ready Professional Therapy System units that were to have been quarantined pending final inspection and testing were inadvertently moved to finishe

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.