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510(k) Data Aggregation
K Number
K051438Device Name
VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM)
Manufacturer
ALLIANCE MEDICAL, INC.
Date Cleared
2006-04-04
(307 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
ALLIANCE MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When coupled with an appropriate inflation system, compression garments are intended to increase venous return from the legs and feet as a prophylaxis for the formation of deep vein thrombosis (DVT) or subsequent pulmonary embolism (PE) in high risk and/or non-ambulatory patients. The compression garments are prescription devices intended for a single patient use only.
Device Description
Compressible limb sleeves are devices that are used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb and increasing venous flow. Compression therapy is generally prescribed as a prophylaxis for deep vein thrombosis (DVT). The compression system consists of two primary pieces: an air compression pump and a soft, flexible sleeve in which the patient's extremity is placed. A hose to the pump connects to the sleeve, and when the pump is turned on, the air inflates the sleeve, applying a gentle pressure to the patient's extremity. Compression garments consist of a non-woven fabric with "hook and loop" fasteners for attaching around the leg. Air cells within the garment are molded to plastic hoses with connectors for attachment to the pump. The hoses and connectors are non-detachable and are reprocessed as part of the garment. Vanguard Reprocessed Compression Garments (Hill-Rom) contain multiple compartments and hoses that are sequentially pressurized. Vanguard receives previously used compression garments from healthcare facilities; cleans, inspects, tests, repackages and sterilizes the garments; and returns them to a healthcare facility.
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K Number
K050518Device Name
REPROCESSED PHACOEMUISIFICATION TIPS
Manufacturer
ALLIANCE MEDICAL, INC.
Date Cleared
2005-09-23
(206 days)
Product Code
NKX
Regulation Number
886.4670Why did this record match?
Applicant Name (Manufacturer) :
ALLIANCE MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Reprocessed Phacoemulsification Tips are intended to emulsify and excise cataract tissues in ophthalmic microsurgical procedures.
Reprocessed Phacoemulsification Tips are indicated for use to emulsify and excise cataract tissues in patients requiring eye surgery.
Device Description
Phacoemulsification Tips are used to emulsify and excise cataract tissue in ophthalmic microsurgical procedures. When connected to the ultrasonic handpiece of a phacoemulsification system and activated, the Phacoemulsification Tip vibrates at an ultrasonic frequency that emulsifies cataract tissue. The extracted tissue is then aspirated away through the hollow tip. Irrigation of the eye with a saline solution compensates for the loss of volume in the eye when the cataract tissue is removed.
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K Number
K030187Device Name
REPROCESSED ELECTROPHYSIOLOGY CATHETER
Manufacturer
ALLIANCE MEDICAL, INC.
Date Cleared
2003-09-24
(246 days)
Product Code
NLH
Regulation Number
870.1220Why did this record match?
Applicant Name (Manufacturer) :
ALLIANCE MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.
Reprocessed Electrophysiology Catheter Cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.
Device Description
Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tips of deflectable catheters can be deflected into a curve by manipulating the handpiece; fixed curve catheters have an established distal tip shape.
Alliance Medical Corporation's reprocessing of electrophysiology catheters includes removal of adherent visible soil and decontamination. Each individual electrophysiology catheter is tested for appropriate function of its components prior to packaging and labeling operations.
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K Number
K021654Device Name
REPROCESSED COMPRESSION SLEEVE
Manufacturer
ALLIANCE MEDICAL, INC.
Date Cleared
2003-02-05
(261 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
ALLIANCE MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Reprocessed Compression Sleeves are intended to help prevent deep vein thrombosis and pulmonary embolism by supplying a measured, intermittent pressure into the compression sleeves worn on the lower extremities of a recumbent patient, resulting in a gradient, sequential, repetitive squeezing and relaxing action, simulating normal muscle contractions.
Reprocessed Compression Sleeves are indicated for use in providing external compression therapy to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism in patients at risk for thrombosis formation.
Device Description
Compression sleeves are part of an external compression system, in which intermittent or sequential compression is provided using a pump/controller and limb garment. The system consists of the following three main components: a control unit, inflatable limb sleeves and conduit tubing with detachable connections.
Alliance Medical Corporation's reprocessing of compression sleeves includes removal of adherent visible soil and decontamination. Each individual compression sleeve is tested for appropriate function of its components prior to packaging and labeling operations.
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K Number
K012634Device Name
REPROCESSED EXTERNAL FIXATION DEVICE
Manufacturer
ALLIANCE MEDICAL, INC.
Date Cleared
2002-06-24
(315 days)
Product Code
KTW, JEC, KTT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
ALLIANCE MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation aand treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.
Device Description
External fixation devices are specially designed frames, clamps, rods, rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixation bolts, washers, nuts, hinges, sockets, connecting bars and screws used for the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Materials used include metal alloys, plastic and composites. These materials are chosen to address a wide range of fractures and applications as well as to allow for the appropriate amount of rigidity and stability.
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K Number
K012630Device Name
REPROCESSED LINVATEC ARTHROSCOPIC BURS
Manufacturer
ALLIANCE MEDICAL, INC.
Date Cleared
2001-11-09
(88 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
ALLIANCE MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Reprocessed Arthroscopic Shavers are intended to resect tissue and bone found in articular body cavities during orthopedic, maxillofacial, hand, foot and plastic surgery in patients requiring arthroscopic or orthopedic surgery.
Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
Device Description
Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses.
The arthroscopic shaver components reprocessed by Alliance Medical Corporation include a bur or blade at the end of a long rod that rotates within a long hollow stainless steel housing.
The housing has a window cut out on one side of the distal end, allowing the bur to cut one structure, while the adjacent one is still protected by the housing on the opposite side of the bur or blade. This system attaches to a motorized handpiece that drives the internal bur or blade inside the outer housing and provides suction to pull the cut tissue and/or bone away from the surgical site.
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K Number
K012611Device Name
REPROCESSED DYONICS ARTHROSCOPIC SHAVERS
Manufacturer
ALLIANCE MEDICAL, INC.
Date Cleared
2001-11-07
(86 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
ALLIANCE MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints, jaw, or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
Device Description
Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses.
The arthroscopic shaver components reprocessed by Alliance Medical Corporation include a bur or blade at the end of a long rod that rotates within a long hollow stainless steel housing. The housing has a window cut out on one side of the distal end, allowing the bur to cut one structure while the adjacent one is still protected by the housing on the opposite side of the bur or blade. This system attaches to a motorized handpiece that drives the internal bur or blade inside the outer housing and provides suction to pull the cut tissue away from the surgical site.
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K Number
K012613Device Name
REPROCSSED LINVATEC SHAVERS
Manufacturer
ALLIANCE MEDICAL, INC.
Date Cleared
2001-11-07
(86 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
ALLIANCE MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Reprocessed Arthroscopic Shavers are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
Device Description
Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses.
The arthroscopic shaver components reprocessed by Alliance Medical Corporation include a burr or blade at the end of a long rod that rotates within a long hollow stain- less steel housing. The housing has a window cut out on one side of the distal end, allowing the burr to cut one structure while the adjacent one is still protected by the housing on the opposite side of the burr or blade. This system attaches to a motorized handpiece that drives the internal burr or blade inside the outer housing and provides suction to pull the cut tissue away from the surgical site.
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K Number
K990198Device Name
AMIB7
Manufacturer
ALLIANCE MEDICAL, INC.
Date Cleared
1999-06-29
(159 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
ALLIANCE MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Musculo-skeletal Conventional.
Device Description
The AMB7 is compact, lightweight and completely self-contained (w12" x h10" x 120") portable multipurpose ultrasound scanning system as are the predicate devices. The device can be carried anywhere for diagnostic purposes. The unit may operate from either a power source of 110vac / 220vac or from its' internal battery. A fully charged battery is able to provide the unit with approximately 1.5 hours of continuous operation. The predicate devices do not provide a means for battery operation. The AMIB7 uses a multi-frequency probe technology to produce high quality images (256 grey scale). The operator can select the best frequency, depending on the probe in use, to optimize near field imaging resolution and far field imaging penetration. The operator can move the focal point deeper through the image to reach the complex focus zone, to provide a better image resolution. The system features several operating modes, as do the predicate devices, and offers the following exam capabilities: B-mode. It is designed to perform Abdominal, Cardiac, and peripheral vascular, Pediatric, Obstetrical/Gynecological, Musculo-skeletal and small parts. The AMIB7 also enables the user to print reports viewed on screen. The AMIB7 allows the user to set up a wide variety of default parameters for easy operation like the predicate devices mentioned above. A sophisticated package of measurements and calculations ( Distance, Area, Circumference, Volume, Heart Rate, Ejection Fraction) are available B and M modes. In obstetric measurements for example, one can use the system equations and pre-programmed comparison tables or can set-up the unit and apply his own tables. The operator of the AMB7 unit can adjust the deplayed echo The system master gain allows the operator to uniformly control the gain level for all parts of the displayed image. The system Time Gain Compensation (TGC) allows for level adjustment of the echo amplification in near and far field (upper and the lower part of the echographic image).
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K Number
K951976Device Name
ECHO. AKHO
Manufacturer
ALLIANCE MEDICAL, INC.
Date Cleared
1996-07-26
(456 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
ALLIANCE MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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