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Found 6 results
510(k) Data Aggregation
K Number
K982950Device Name
FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550
Manufacturer
CHALGREN ENTERPRISES, INC.
Date Cleared
1999-06-22
(305 days)
Product Code
IKT
Regulation Number
890.1385Why did this record match?
Applicant Name (Manufacturer) :
CHALGREN ENTERPRISES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fine wire electrodes are supplied preloaded into a needle assembly. The needle is inserted into human muscle tissue and then removed, leaving the fine wires implanted for a short term. An adaptor cable is attached to the fine wires and then connected to an EMG instrument for electromyographic (EMG) diagnostic tests.
This device is intended for use by licensed physicians. Physicians using this device are well trained in the use of EMG electrodes, their placement, and proper use of related EMG instruments.
The fine wire electrodes are designed to record electrical activity in muscle tissue. As recording electrodes, there is no risk of damage to the tissue from electrical current.
Fine wire electrodes allow for multiple tests without additional needle sticks.
Device Description
Fine wire electrodes are supplied preloaded into a needle assembly. The needle is inserted into human muscle tissue and then removed, leaving the fine wires implanted for a short term. An adaptor cable is attached to the fine wires and then connected to an EMG instrument for electromyographic (EMG) diagnostic tests.
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K Number
K960591Device Name
RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP
Manufacturer
CHALGREN ENTERPRISES, INC.
Date Cleared
1996-06-13
(122 days)
Product Code
IKT
Regulation Number
890.1385Why did this record match?
Applicant Name (Manufacturer) :
CHALGREN ENTERPRISES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K955335Device Name
DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE
Manufacturer
CHALGREN ENTERPRISES, INC.
Date Cleared
1996-01-29
(70 days)
Product Code
IKT
Regulation Number
890.1385Why did this record match?
Applicant Name (Manufacturer) :
CHALGREN ENTERPRISES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K953354Device Name
EMG DISC RECORDING ELECTRODE
Manufacturer
CHALGREN ENTERPRISES, INC.
Date Cleared
1996-01-22
(189 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
CHALGREN ENTERPRISES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K953356Device Name
EMG RECORDING RING ELECTRODE
Manufacturer
CHALGREN ENTERPRISES, INC.
Date Cleared
1996-01-22
(189 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
CHALGREN ENTERPRISES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
EMG Recording Ring Electrode
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K Number
K953361Device Name
EMG DISC RECORDING ELECTRODE
Manufacturer
CHALGREN ENTERPRISES, INC.
Date Cleared
1996-01-22
(189 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
CHALGREN ENTERPRISES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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