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510(k) Data Aggregation
K Number
K211937Device Name
SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System
Manufacturer
Date Cleared
2021-11-18
(149 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Synecoun Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used to:
- · Aid in the prevention of DVT;
- · Enhance blood circulation:
- · Diminish post-operative pain and swelling;
- · Reduce wound healing time;
• Aid in the treatment and healing of: stasis dernatits, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
· As a prophylaxis for DVT by persons expecting to be stationary for long periods of time.
Device Description
SyneCare 1100 Deep Vein Thrombosis Prevention Thereinafter as SyneCare 1100) is an ambulatory, portable, light weight, prescriptive device intermittent pneumatic compression system intended to provide sequential compression therapy to a patient's lower limbs. The SyneCare 1000 system consists of a pair of pumps and sleeve assemblies, in which each sleeve has 2 compression chambers.
The device will alternatively inflate and deflate the sleeve to stimulate blood flow in the extremities (muscle contraction). The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle. There are three default modalities. Mode 1 is inflating chamber 1 up to the preset pressure and then deflating, and then inflating chamber 2 up to the preset pressure and then deflating, and repeat the above process with an interval of 40 seconds. Mode 2 is inflating chamber 1 up to the preset pressure and then inflating chamber 2 up to the preset pressure, then deflating at the same time. The above process is repeated with an interval of 40 seconds. The third mode is inflating chamber 1& 2 simultaneously to the preset pressure (50mmHg) and hold for 9 seconds, then deflating to the preset pressure (40mmHg) at the same time and hold for 10 seconds, and then deflating. The above process is repeated with an interval of 30 seconds.
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K Number
K203310Device Name
SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System
Manufacturer
Date Cleared
2021-04-02
(143 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Synecoun Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Synecare 1000 deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).
This device can be used in the home or clinical settings to:
· Aid in the prevention of DVT
- · Enhance blood circulation
· Diminish post-operative pain and swelling
- · Reduce wound healing time
· Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs
· As a prophylaxis for DVT by persons expecting to be stationary for long periods of time
Device Description
The SyneCare 1000 deep vein thrombosis prevention therapy system (referred as SyneCare 1000 below) is an easy to use portable pneumatic compression system that noninvasively helps prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). The SyneCare 1000 system consists of a pair of pumps and sleeve assemblies.
The device will alternatively inflate and deflate the garment (sleeve) to stimulate blood flow in the extremities (muscle contraction). The device provides a 50mmHg pressure and followed by a deflation period once it reaches the desired pressure, each cycle time is 60 seconds
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