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510(k) Data Aggregation
K Number
K141390Device Name
INTERMITTENT PNEUMATIC COMPRESSION DEVICE
Manufacturer
Date Cleared
2014-11-18
(175 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
WUHAN LANDING MEDICAL HI-TECH LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The LD Q-IPC III is a system to prevent DVT(Deep Vein Thrombosis) by improving the blood velocity of patients.
Leg Compression
The use of the product with Calf Cuff and Thigh Cuff is indicated for:
1. Deep vein thrombosis and pulmonary embolism prophylaxis.
Foot Compression
The use of the product with Foot Cuff is indicated for:
1. Circulation enhancement.
2. Deep vein thrombosis prophylaxis.
3. Edema-Acute.
4. Edema-Chronic.
5. Extremity pain incident to trauma or surgery.
6. Leg Ulcers.
7. Venous stasis /Venous insufficiency.
Device Description
The LD Q-IPC III Intermittent pneumatic compression device is a pneumatic compression device that noninvasively helps reduce the incidence of deep vein thrombosis, a potentially life threatening condition.
The LD Q-IPC III Intermittent pneumatic compression device consists of the controller, the Tubing Sets and single-patient used cuff. The cuff includes calf cuffs, thigh cuffs and foot cuffs.
The controller will deliver air to the cuffs and sequentially pressurize them. Cuffs will be pressurized from the distal air chamber to the proximal air chamber. After the compression, the controller will allow an interval time for vein refilling, before the controller starts to pressurize the cuffs again. The cycles will be repeated throughout the time the unit is in use or for the duration of the default operating time.
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