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510(k) Data Aggregation
K Number
K132422Device Name
PALS PLATINUM NEUROSTIMULATION ELECTRODES
Manufacturer
AXELGAARD MFG. CO., LTD.
Date Cleared
2014-02-13
(192 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
AXELGAARD MFG. CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PALS® reusable, self-adhering, over-the-counter Neurostimulation Electrodes are indicated for use with transcutaneous electrical stimulation devices. Some common types of transcutaneous stimulation devices include, but are not limited to, transepithelial nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices. Transcutaneous Neurostimulation Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device.
Device Description
The Axelgaard PALS® Neurostimulation reusable self-adhering electrode is used as a transcutaneous electrical nerve stimulation electrode in conjunction with an electrical stimulator for TENS or EMS.
The device functions as a passive device by carrying an electrical signal from a neurostimulation device through the device cable and electrode lead wire to the user skin. It is composed of a cover, connector lead wire, strelchable conductive fabric, conductive hydrogel, and an electrode carrier distribution is delivered via a connector lead wire stripped to an additional length.
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K Number
K130987Device Name
VALUTRODE NEUROSTIMLATION ELECTRODES
Manufacturer
AXELGAARD MFG. CO., LTD.
Date Cleared
2013-07-17
(99 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
AXELGAARD MFG. CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ValuTrode® reusable, self-adhering, over-the-counter Neurostimulation Electrodes are indicated for use with transcutaneous electrical stimulation devices. Some common types of transcutaneous stimulation devices include, but are not limited to, transepithelial nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices. Transcutaneous Neurostimulation Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device.
Device Description
The ValuTrode® reusable self-adhering electrode is used as a transcutaneous electrical nerve stimulation electrode in conjunction with an electrical stimulator for TENS or EMS. The device functions as a passive device by carrying an electrical signal from a neurostimulation device through the device cable and electrode lead wire to the user skin. It is composed of a cover, connector lead wire, or snap, conductive carbon film, conductive hydrogel, and an electrode carrier liner. Proper current distribution is delivered via a connector lead wire stripped to an additional length, or use of a printed silver pattern.
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K Number
K080580Device Name
COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D
Manufacturer
AXELGAARD MFG. CO., LTD.
Date Cleared
2008-06-18
(107 days)
Product Code
EGJ
Regulation Number
890.5525Why did this record match?
Applicant Name (Manufacturer) :
AXELGAARD MFG. CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Iontophoresis is indicated by clinicians for the administration of soluble salts or other drugs into the body for medical purposes and can be used as an alternative to hypodermic injection.
Device Description
Comfort Iontophoresis Electrodes (Buffered Iontophoresis Electrode Treatment Kit) consist of an active drug delivery electrode and a passive return electrodes are designed for one use on a single patient for the local administration of ionic drug solutions into the body for medical purposes. There are four sizes and for the roundinen a releaser of roles to accommodate placement on various locations on the body. The size of the return electrode is the same for all drug delivery electrode sizes as the maximum delivery of 80 milliamp-minutes is the same regardless of size. Comfort Iontophoresis Electrodes (Buffered Iontophoresis Electrode Treatment Kit) have technological characteristics equivalent to those of the predicate devices, including comparable design, materials, multiple shapes and sizes of active drug delivery electrodes, and equivalent packaging and abeling.
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K Number
K013532Device Name
ULTRASTIM KIT
Manufacturer
AXELGAARD MFG. CO., LTD.
Date Cleared
2002-08-22
(309 days)
Product Code
GZJ, GXY, IQE
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
AXELGAARD MFG. CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UltraStim Kit is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
Device Description
Not Found
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K Number
K000947Device Name
ULTRASTIM ELECTRODE, MODEL US4040
Manufacturer
AXELGAARD MFG. CO., LTD.
Date Cleared
2000-06-16
(85 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
AXELGAARD MFG. CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000206Device Name
PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200
Manufacturer
AXELGAARD MFG. CO., LTD.
Date Cleared
2000-04-13
(83 days)
Product Code
DRX
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
AXELGAARD MFG. CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K983741Device Name
EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020
Manufacturer
AXELGAARD MFG. CO., LTD.
Date Cleared
1998-12-18
(57 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
AXELGAARD MFG. CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Everlast Neurostimulation Electrodes are intended for use with transcutaneous neurostimulation devices.
Device Description
Not Found
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K Number
K970426Device Name
VALUETRODE
Manufacturer
AXELGAARD MFG. CO., LTD.
Date Cleared
1997-05-09
(94 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
AXELGAARD MFG. CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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