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510(k) Data Aggregation
K Number
K131817Device Name
EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
Manufacturer
OSMUNDA MEDICAL DEVICE CONSULTING CO., LTD.
Date Cleared
2014-09-26
(463 days)
Product Code
LNS
Regulation Number
876.5990Why did this record match?
Applicant Name (Manufacturer) :
OSMUNDA MEDICAL DEVICE CONSULTING CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CS-2012A-3 is intended for use by attending physician in the treatment of all kinds of calculi in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
Device Description
ESWL, model CS-2012A-3, is an mobile electromagnetic lithotripter with a focal zone to treat patients, the shock wave generator has a high voltage power supply, a closed circuit water supply system with a tank, an spherical concave electromagnetic coil, a membrane and a water cushion (rubber membrane) for the acoustic conductivity of the shock waves to the patient.
It is intended to be used properly by trained and qualified medical personnel for use in noninvasive fragmentation of urinary calculi in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
The shock waves are generated by the high voltage discharge through the electromagnetic coil which repels the membrane creating a shockwave. The shockwave is then focused to the focal point. The stones to be fragmented are positioned at this focal point by moving the motorized patient table in 3 axis. The localization is performed with a separate and commercially available mobile fluoroscopic x-ray unit and/or US equipment.
The device includes following parts:
1. ESWL device
The ESWL device contains therapy head, main switch, control panel, target indicator and foot pedal. It also provides patient with treatment, controls functions of CS-2012A-3.
2. Therapy table
Therapy table consists of table (For personal hygiene, the table should be covered by disposable medical nonwoven fabrics in treatment), table supporter and 3-dimension movement.
Patient is positioned on therapy table. Table cutout area allows positioning of therapy table near patient, table can be moved as required. Table motion is completely independent of ESWL device. It has its own 3 dimension movement, not to link CS-2012A-3.
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