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Found 10 results
510(k) Data Aggregation
K Number
K012802Device Name
MP3CF ELECTRIC WHEELCHAIR
Manufacturer
MERITS HEALTH PRODUCTS., INC.
Date Cleared
2001-09-18
(28 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
MERITS HEALTH PRODUCTS., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the MPCF is to provide mobility to adults, limited to a sitting position that have the capability to operate a few simple controls and the ability to control a power wheelchair.
Device Description
Not Found
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K Number
K011844Device Name
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
Manufacturer
MERITS HEALTH PRODUCTS., INC.
Date Cleared
2001-08-28
(77 days)
Product Code
CAW
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
MERITS HEALTH PRODUCTS., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Oxygen Concentrator is indicated for the delivery of supplemental oxygen in the home or medical institutions. The device is not intended for life support nor does it provide any patient monitoring capabilities.
Device Description
The Merits Health Products Oxygen Concentrators are prescription devices designed to provide an inexpensive supply of supplemental oxygen in a home or institution without a continuous source of purified oxygen. They are not lifesupporting nor life-sustaining devices. The devices operate through the use of molecular sieve material that binds with the water and nitrogen in filtered room air to leave a gas that is approximately 93% oxygen when delivered to the patient. The compressor creates a vacuum to draw room air into a holding tank. At the same time, downstream of the compressor, the air from the previous cycle is pressurized into one of the two aluminum welded molecular sieve tanks. As the oxygen is forced out of the end of the tank, it enters a 'T' fitting that directs most of the gas to flush the nitrogen out of the second molecular sieve tank into the ambient air. The remaining oxygen is delivered to the patient. On the next cycle, the air is directed into the second molecular sieve tank with the oxygen generated flushing the first tank and continuing the supply to the patient. This repetitive cycle generates the oxygen necessary to flush and prepare the saturated sieve tank while supplying the patient with a continuous flow of high concentration oxygen. Other options will include an Oxygen alarm and a pediatric flowmeter.
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K Number
K011513Device Name
MP3U, POWER WHEELCHAIR
Manufacturer
MERITS HEALTH PRODUCTS., INC.
Date Cleared
2001-08-10
(86 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
MERITS HEALTH PRODUCTS., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K011751Device Name
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3
Manufacturer
MERITS HEALTH PRODUCTS., INC.
Date Cleared
2001-08-06
(61 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
MERITS HEALTH PRODUCTS., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the MERITS Pioneer 3 Powered Scooter is to provide mobility to adults, limited to a siting position and have the capability to operate a simple hand control.
Device Description
MERITS Pioneer 3 Electric powered four wheel drive scooter
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K Number
K011687Device Name
MP-3C POWER BASE CHAIR, MODEL MP3C
Manufacturer
MERITS HEALTH PRODUCTS., INC.
Date Cleared
2001-08-03
(64 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
MERITS HEALTH PRODUCTS., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the MP3C is to provide mobility to adults, who have the capability to operate a few simple controls and the ability to control a power wheelchair.
Device Description
MP3C Power Base Chair, Model MP3C
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K Number
K011753Device Name
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4
Manufacturer
MERITS HEALTH PRODUCTS., INC.
Date Cleared
2001-08-03
(58 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
MERITS HEALTH PRODUCTS., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of Travel Ease Electric Scooter, Pioneer 4 is to provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.
Device Description
Travel Ease Electric Scooter, Pioneer 4
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K Number
K010380Device Name
MP3HD BIG BOY, POWER WHEELCHAIR
Manufacturer
MERITS HEALTH PRODUCTS., INC.
Date Cleared
2001-05-09
(90 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
MERITS HEALTH PRODUCTS., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003815Device Name
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER
Manufacturer
MERITS HEALTH PRODUCTS., INC.
Date Cleared
2000-12-27
(16 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
MERITS HEALTH PRODUCTS., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993032Device Name
MODIFICATION TO MP-3 POWER BASE CHAIR
Manufacturer
MERITS HEALTH PRODUCTS., INC.
Date Cleared
1999-11-05
(87 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
MERITS HEALTH PRODUCTS., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Merits Health Products MP3 is a handicap piece of equipment and it is used to assist disabled people to negotiate their daily living. People with muscular disease use this chair to improve their daily living.
Device Description
MP-3 Power Base Chair
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K Number
K982066Device Name
MP-3 POWER BASE CHAIR
Manufacturer
MERITS HEALTH PRODUCTS., INC.
Date Cleared
1998-08-31
(81 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
MERITS HEALTH PRODUCTS., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Merits MP-3 power base wheelchair will be used by handicapped people who are unable to ambulate. People who cannot ambulate and have weak upper body strength and cannot propel a manual wheelchair will be the ones who will benefit from the use of the MP-3 power base wheelchair.
Device Description
MP-3 Power Base Chair
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