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510(k) Data Aggregation
K Number
K150005Device Name
Checkpoint, Checkpoint Head & Neck
Manufacturer
Date Cleared
2015-02-19
(48 days)
Product Code
Regulation Number
874.1820Why did this record match?
Applicant Name (Manufacturer) :
NDI Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Checkpoint® Head & Neck is a single-use device intended to provide electrical stimulation of exposed motor nerves or muscle tissue to locate and identify nerves and to test nerve and muscle excitability.
Device Description
The Checkpoint Head & Neck is a small handheld device used by a surgeon to deliver electrical stimulation intraoperatively to locate and identify nerves, and to test nerve integrity and muscle excitability. These are sterile disposable devices designed to use with one-handed control.
The device uses a stimulating probe that is attached to the distal end and a cable attached to a needle return electrode on the proximal end. The microcontroller in the device includes embedded firmware that controls the function of the Stimulator. The firmware cannot be modified by the user. The stimulator is powered by internal batteries that are not user replaceable, thereby minimizing the potential for re-use.
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K Number
K061365Device Name
CHECKPOINT WITH ACCUSTIM TECHNOLOGY
Manufacturer
Date Cleared
2006-07-12
(57 days)
Product Code
Regulation Number
874.1820Why did this record match?
Applicant Name (Manufacturer) :
NDI MEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Checkpoint™ is a single-use device intended to provide electrical stimulation of exposed motor nerves or muscle tissue to locate and identify nerves and to test nerve and muscle excitability.
Device Description
The Checkpoint™ is a small handheld device used by a surgeon to deliver electrical stimulation intraoperatively to test nerve integrity and muscle excitability. This is a sterile disposable device designed to be simple to use with one-handed control.
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Ask a specific question about this device
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