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510(k) Data Aggregation
K Number
K061343Device Name
INSPIRSTAR GLOVE ELECTRODE
Manufacturer
Date Cleared
2006-05-31
(16 days)
Product Code
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
INSPIRSTAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Inspirstar Glove Electrode is intended to for use with legally marketed electrostimulation devices such as TENS to deliver stimulation current for pain relief.
Inspirstar Glove Electrode is cutaneous electrode to be used with legally marketed TENS stimulating device. The glove electrodes will deliver the stimulation signals generated by the stimulator to the skin with which they are contact.
Device Description
Inspirstar Glove Electrode is the conductive glove knitted from a continuous silver coated nylon yarn into the form of the glove. The conductivity is derived from the silver material of nylon yarn. Nylon yarn provides elasticity which can ensure skin contact. Inspirstar Glove Electrode has the same conductivity for dry or wet usage. The entire glove electrode is conductive having the resistance of less than 7 ohms per inch consistently.
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K Number
K060368Device Name
INSPIRSTAR IS02 MICROCURRENT STIMULATOR
Manufacturer
Date Cleared
2006-03-14
(29 days)
Product Code
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
INSPIRSTAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Inspirstar IS02 Microcurrent Stimulator is intended to be used for the symptomatic relief of chronic intractable pain.
Device Description
Inspirstar IS02 Microcurrent Stimulator is a Microcurrent TENS device intended to be used for the symptomatic relief of chronic intractable pain. This product can generate low current intensity pulses at microampere level and frequency of pulses. The unit supports five pre-defined therapy programs. The current intensity, frequency, time, etc. are programmable by doctors.
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