Search Results
Found 2 results
510(k) Data Aggregation
K Number
K193662Device Name
Ezlymph, Ezlymph M
Manufacturer
Date Cleared
2021-02-11
(408 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Eezcare Medical Corp
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
EzLymph and EzLymph M are intended to treat lymphedema.
Device Description
EzLymph and EzLymph M is a pump system intended to apply intermittent pneumatic compression (IPC) to arms and legs to relieve the discomfort of lymphedema. The device helps move the flow of lymphatic and venous fluid throughout the extremities by stimulating muscles within the affected extremity. This action mimics natural muscle contractions, improves circulation, and moves excess fluid back to the circulatory system so edema can be eliminated from the body. System components include (a) a mains-powered, portable pneumatic pump with a pressure-control knob and on/off switch (the device contains no control panel or microprocessor circuit); (b) connecting air hoses; and (c) compression garments attached to patient limbs. In addition, garment inserts allow increase in circumference of arm and leg garments. The pump intermittently releases compressed air through the tubing into inflating and deflating bladders within cuffs that are wrapped separately around the patient's upper and lower limbs (full arm, full leg, and half leg).
Ask a Question
Ask a specific question about this device
K Number
K191937Device Name
Ezvena IPC, Ezvena SQS
Manufacturer
Date Cleared
2020-01-29
(194 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Eezcare Medical Corp
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To apply intermittent pneumatic compression to the lower limbs to help prevent deep vein thrombosis.
Device Description
EzVena IPC and EzVena SQS ("EzVena") is a deep vein thrombosis (DVT) pump system intended for performing non-invasive, intermittent compression of the lower limbs. The system is used to squeeze blood from the deep veins, which displaces proximally. On deflation of the cuff, the veins refill, and the intermittent nature of the system ensures periodic flow of blood through the deep veins, helping to prevent venous stasis and the formation of blood clots. System components include a mains-powered, pneumatic pump with touch-input control panel and microprocessor circuit; connecting air hoses; and foot, calf, and calf/thigh garments, or cuffs. The pump intermittently releases compressed air through the tubing into inflating and deflating bladders within cuffs that are wrapped separately around the patient's left and right lower limbs. Compression is uniform in the IPC model and graded sequential in the SQS model. The system alternates between left and right cuffs in EzVena IPC and inflates both garments simultaneously in EzVena SQS.
Ask a Question
Ask a specific question about this device
Page 1 of 1