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510(k) Data Aggregation
K Number
K072887Device Name
G-TRAINER MEDICAL
Manufacturer
ALTER-G, INC.
Date Cleared
2008-01-25
(107 days)
Product Code
BXB
Regulation Number
890.5380Why did this record match?
Product Code :
BXB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Alter-G G-Trainer is indicated for use in the following conditions:
Aerobic conditioning Weight control and reduction Sport specific conditioning programs Gait training in neurologic patients Strengthening and conditioning in older patients Rehabilitation following injury or surgery of the lower extremity Rehabilitation following injury or surgery of the hip, knee, ankle or foot. Rehabilitation after total joint replacement
Device Description
The G-Trainer is designed to provide an adjustable weight support while the user exercises on the incorporated treadmill. The G-trainer is comprised of a standard exercise treadmill with an integrated unweighting component that can effectively reduce the body weight of an individual while they exercise. A bag that looks much like a small tent is placed over the running surface of the treadmill and sealed in such a manner that an electric blower can inflate the bag. The subject wears a special pair of shorts that zip into the top and center of the bag much like the skirt used on a kayak. The subject zips into the bag and stands on the surface of the treadmill. Using a touch screen control panel, the subject is able to increase or decrease the pressure in the bag. The pressure in the bag provides weight support for the user. By this method. the effective weight of the subject on the treadmill surface can be precisely controlled while they exercise.
The G-Trainer is comprised of a base frame, a treadmill, an upper support frame, the inflatable bag, a pressure source and regulation system, control electronics and a control console.
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K Number
K003272Device Name
FLO-BOOT
Manufacturer
DISCOVERY GROUP LLC.
Date Cleared
2001-04-04
(168 days)
Product Code
BXB
Regulation Number
890.5380Why did this record match?
Product Code :
BXB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K952975Device Name
ANKLE CALF EXERCISER PHLEBOPUMP
Manufacturer
PREVENT PRODUCTS, INC.
Date Cleared
1996-09-25
(456 days)
Product Code
BXB
Regulation Number
890.5380Why did this record match?
Product Code :
BXB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ACE/PP is intended to exercise the lower leg to help prevent vein thrombosis secondary to venous stasis and blood pooling in the leg. It also retains the exercise function for maintaining muscle tone and preventing stiffness in the ankle joints.
Device Description
The ACE/PP is a compact portable exercise device with motor driven foot paddles. The product is controlled by the staff or the patient via an air switch. The paddles are driven in a natural and gentle dorsiflex motion.
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K Number
K953456Device Name
E-Z FLEX
Manufacturer
FLUID MOTION BIOTECHNOLOGIES, INC.
Date Cleared
1996-01-26
(191 days)
Product Code
BXB
Regulation Number
890.5380Why did this record match?
Product Code :
BXB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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