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510(k) Data Aggregation
K Number
K083756Device Name
GUARDIAN 150 ELECTRODE
Manufacturer
SELECTIVE MED COMPONENTS, INC.
Date Cleared
2009-06-26
(191 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
SELECTIVE MED COMPONENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Guardian 150 electrode is intended for use with TENS and NMES, including for Muscle reeducation by application of external stimulation to the muscles necessary for pharyngeal contraction.
Device Description
Guardian 150 electrode is a single-patient, single use, self-adhering electrode for use with TENS and NMES, and available in cloth (models 150. 151. 152 and 3637), pre-wired (model 3637), snap (models 150, 151 and 152) and pin style (model 3637) configurations. It is latexfree.
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K Number
K031053Device Name
SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7
Manufacturer
SELECTIVE MED COMPONENTS, INC.
Date Cleared
2003-05-20
(48 days)
Product Code
EGJ
Regulation Number
890.5525Why did this record match?
Applicant Name (Manufacturer) :
SELECTIVE MED COMPONENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery Electrodes are intended to be used to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection.
Selective Med Components, Inc., Buffered Iontophoresis Drug Delivery System Electrodes are indicated to introduce ions of soluble salts or other drugs into the body.
Device Description
The Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery Electrode System consists of an active drug delivery electrode and a passive return electrode. These electrodes are designed for one use by a single patient for the local administration of ionic drug solutions into the body for medical purposes. There are multiple sizes and shapes of drug delivery electrodes to accommodate placement various sites on the body. The size of the return electrode is the same for all drug delivery electrode sizes. The SMC Buffered Iontophoresis Drug Delivery Electrodes have technological characteristics equivalent to those of the predicate devices, including comparable performance specifications, comparable materials including the same buffering agent (Ag/AgCl) and fiberous polyester reservoir materials on the active drug delivery electrodes and the same buffering, self-adhering polymer on the return electrode, multiple shapes and sizes of active the drug delivery electrodes, and equivalent packaging and labeling.
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K Number
K020476Device Name
MEDION 6000
Manufacturer
SELECTIVE MED COMPONENTS, INC.
Date Cleared
2002-05-03
(80 days)
Product Code
EGJ
Regulation Number
890.5525Why did this record match?
Applicant Name (Manufacturer) :
SELECTIVE MED COMPONENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes, as an alternative to hypodermic injection when it is advisable to avoid the pain that may accompany needle insertion and drug injection, and when it is advisable to minimize the infiltration of carrier fluids or to avoid the damage that may be caused by needle insertion when tissue is traumatized.
Device Description
The iontophoresis device is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes. The iontophoretic technology operates on the principle that an electic potential will cause ions in solution to migrate according to their electrical charges. Further, the quantity and distribution of a drug delivered into or across the skin by iontophoresis is dependent upon the charge and size (molecular weight) of the ion, strength of the electircal current being applied, electrode composition, duration of current flow and several other factors. The Medion™ is a battery-powered, solid state, microprocessor controlled device which controls current strength and duration, calculates total charge delivered and monitors current flow and electrode/tissue impedance.
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K Number
K993081Device Name
IO-DRIVE
Manufacturer
SELECTIVE MED COMPONENTS, INC.
Date Cleared
2000-03-03
(170 days)
Product Code
EGJ
Regulation Number
890.5525Why did this record match?
Applicant Name (Manufacturer) :
SELECTIVE MED COMPONENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Io-Drive electrode is indicated to introduce ions of soluble salts and other drugs into body.
Device Description
The IO-Drive Iontophoresis electrode system consists of an active drug delivery electrode and a return electrode. These electrodes are designed for single patient use. There are multiple sizes of drug delivery electrodes to accommodate placement at different body sites. The size of the return electrode is the same size for all drug delivery electrodes.
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