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510(k) Data Aggregation
K Number
K971914Device Name
TECA NCS ELECTRODE SYSTEM 2000
Manufacturer
MEDELEC, INC. D.B.A. TECA CORP.
Date Cleared
1998-03-26
(307 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
MEDELEC, INC. D.B.A. TECA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NCS Electrode System 2000 is for electromyographic recording, stimulating, and referencing in motor, sensory nerve conduction, and volitional electromyography.
Device Description
Not Found
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K Number
K973442Device Name
TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
Manufacturer
MEDELEC, INC. D.B.A. TECA CORP.
Date Cleared
1997-11-20
(70 days)
Product Code
IKT
Regulation Number
890.1385Why did this record match?
Applicant Name (Manufacturer) :
MEDELEC, INC. D.B.A. TECA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The disposable hypodermic monopolar needles are FOR SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, in the form of a probe, into a patient to locate a particular muscle and then inject a medication into that muscle. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug delivery. Once the physician is satisfied with the location, he/she injects a drug therein via the lumen of the needle.
Device Description
Not Found
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K Number
K973444Device Name
TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES
Manufacturer
MEDELEC, INC. D.B.A. TECA CORP.
Date Cleared
1997-11-20
(70 days)
Product Code
IKT, IKE
Regulation Number
890.1385Why did this record match?
Applicant Name (Manufacturer) :
MEDELEC, INC. D.B.A. TECA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The disposable hypodermic monopolar needles are FOR SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, in the form of a probe, into a patient to locate a particular muscle and then inject a medication into that musche. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug, delivery. Once the physician is satisfied with the location, he/she injects a very. therein via the lumen of the needle.
Device Description
Disposable Hypodermic Needle Electrode
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