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510(k) Data Aggregation
K Number
K192358Device Name
Pressure Therapy System PT1003
Manufacturer
Xiamen Senyang Co., Ltd.
Date Cleared
2020-04-23
(238 days)
Product Code
IRP
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
Xiamen Senyang Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
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K Number
K181409Device Name
Pressure Therapy System PT1003
Manufacturer
Xiamen Senyang Co., Ltd.
Date Cleared
2019-02-19
(265 days)
Product Code
IRP
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
Xiamen Senyang Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 following trauma and sport injuries, 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.
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K Number
K161907Device Name
Pressure Therapy System
Manufacturer
XIAMEN SENYANG CO., LTD.
Date Cleared
2017-02-23
(226 days)
Product Code
IRP
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
XIAMEN SENYANG CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 lymphedema, edema following trauma and sport injuries, post immobilization edema, venous insufficiencies, lymphedema.
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.
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