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510(k) Data Aggregation
K Number
K070336Device Name
STOCKERT NEURO N50, MODEL12267
Manufacturer
STOCKERT GMBH
Date Cleared
2007-06-14
(129 days)
Product Code
GXD
Regulation Number
882.4400Why did this record match?
Applicant Name (Manufacturer) :
STOCKERT GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Stockert NEURO N50 is a RF generator for general high frequency applications:
1. Lesioning nerve tissue for functional neurosurgical procedures; or
2. Radiofrequency heat lesion procedures for the relief of pain; or
3. Stimulation procedures like provoking stimulation, localized stimulation, blocking stimulation or intraoperative test stimulation
Device Description
The system consists of a radio frequency generator and accessories intended for neurological applications. Its purpose is to generate RF energy for delivery to a site in neurological tissue via a neurological instrument for a specified time period. The thermal energy emitted at the site of application produces a lesio that interrupts an electrical active area of neurological tissues. The STOCKERT NEURO N50 can be used either in bipolar or unipolar mode and includes functions for controlling temperature at the tip of the instrument and for monitoring impedance. It also has a unit for stimulation for provoking, localized, blocking and intraoperative test stimulation.
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K Number
K070134Device Name
MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098
Manufacturer
STOCKERT GMBH
Date Cleared
2007-03-22
(65 days)
Product Code
BXN
Regulation Number
868.2775Why did this record match?
Applicant Name (Manufacturer) :
STOCKERT GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Stimuplex® HNS 12 is a peripheral nerve stimulator used to test the level of pharmacological effects of anaesthetic drugs and gases to the patient and/or as a nerve locator for the verification of needle placement for the application of local anaesthetics. This device can be used wherever peripheral anaesthesia is normally applied (i.e. physicians office or hospital).
Device Description
The nerve stimulator Stimuplex® HNS 12 is a battery powered peripheral nerve stimulator for localization of nerve fibers in the tissue. During the operation the operating physician holds a stimulation cannula in his right hand. Simultaneous the operation of the device happens with his left hand. The physician can hold the device with the left hand and simultaneous alter the stimulation amplitude at the amplitude controller. The Stimuplex® HNS 12 generates negative, current-stabilized square pulses with selectable frequency, selectable pulse width and fine adjustable stimulation current. The pulse is shaped at both slopes by extremely fast active pulse drivers. An output amplifier specially designed for this application has an extraordinarily wide dynamic range and produces reproducible settings even below 0.1 mA. The stimulation frequency and the pulse width can be varied for different applications. The Stimuplex® HNS 12 nerve stimulator offers the facility for selecting a frequency of either 1 Hz or 2 Hz together with pulse widths of 0.1 ms, 0.3 ms or 1.0 ms. Two additional pulse widths: 0.05 ms and 0.50 ms can be enabled in options menu. Stimuplex® HNS 12 has a menu structure (in 26 languages) where the switch on parameters and options and setup parameters like tone volume, contrast, automatically switch off time, language can be configured. The battery voltage is in info menu in volt and percentage and during stimulation menu as symbol displayed.
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K Number
K061983Device Name
STIMUPLEX PEN
Manufacturer
STOCKERT GMBH
Date Cleared
2006-11-21
(131 days)
Product Code
BXN
Regulation Number
868.2775Why did this record match?
Applicant Name (Manufacturer) :
STOCKERT GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Stimuplex® Pen is a cutaneous stimulation electrode for locating superficial peripheral nerves through the skin in local/regional anaesthesia, lor looding openhold peripieral hervey. Ban invesive device non invasive device.
Device Description
The Stimuplex® Pen is an electrode for cutaneous stimulation which, when connected to the Stimuplex® HNS 11 or HNS 12 nerve stimulator and placed on the skin, it conducts electrical impulses which initiates muscular contractions and/or synchronous electrical paresthesia whitin the distribution area of a nerve. The nerve passes perpendicularly to the place where a response is observed at the lowest level of current. This designated point of needle entry is situated directly perpendicular with the nerve.
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K Number
K052313Device Name
STIMUPLEX HNS-12, MODEL 4892098
Manufacturer
STOCKERT GMBH
Date Cleared
2005-11-17
(84 days)
Product Code
BXN
Regulation Number
868.2775Why did this record match?
Applicant Name (Manufacturer) :
STOCKERT GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Stimuplex HNS-12 is a peripheral nerve stimulator used to test the level of pharmacological effects of anesthetic drugs and gases to the patient and/or as a nerve locator for the verification of needle placement for the application of local anesthetics. This device can be used wherever peripheral anesthesia is normally applied (i.e. physicians office or hospital).
Device Description
The nerve stimulator Stimuplex® HNS 12 is a battery powered peripheral nerve stimulator for localization of nerve fibers in the tissue. During the operation the operating physician holds a stimulation cannula in his right hand. Simultaneous the operation of the device happens with his left hand. The physician can hold the device with the left hand and simultaneous alter the stimulation amplitude at the amplitude controller. The technical data of the device are: Battery: 9 Volt alkaline, Display: 1 graphic LCD Module, 1 tricolor (green, yellow, red) LED for status display, Operation: 1 control button to switch on/off the device, Adjustment knob to adjust the wanted stimulation current, 3 control buttons to switch the stimulation parameters, 4 control buttons for navigation and settings in the menus, Remote control (optional stimulation current adjustment), Power consumption: 6 mA (8 mA max in warning/alarm state), Stimulation current : max. 5mApp / 0Ω - 12 kΩ, Stimulation voltage : max. 95 Vpp, Stimulation frequency : 1 Hz / 2 Hz, Flowing current measuring tolerance: +/- 0.02 mA, Weight: 0.25 kg (with battery). The configuration of the electrode connection is realized with a 4 pin plug connection system, which ensures correct polarity of the electrode at all times. The Stimuplex® HNS 12 generates negative, current-stabilized square pulses with selectable frequency, selectable pulse width and fine adjustable stimulation current. The pulse is shaped at both slopes by extremely fast active pulse drivers. An output amplifier specially designed for this application has an extraordinarily wide dynamic range and produces reproducible settings even below 0.1 mA. The stimulation frequency and the pulse width can be varied for different applications. The Stimuplex® HNS 12 nerve stimulator offers the facility for selecting a frequency of either 1 Hz or 2 Hz together with pulse widths of 0.1 ms, 0.3 ms or 1.0 ms. Two additional pulse widths: 0.05 ms and 0.50 ms can be enabled in options menu. Stimuplex® HNS 12 has a menu structure (in 26 languages) where the switch on parameters and options and setup parameters like tone volume, contrast, automatically switch off time, language can be configured. The battery voltage is in info menu in volt and percentage and during stimulation menu as symbol displayed.
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K Number
K003983Device Name
STIMUPLEX HNS-11
Manufacturer
STOCKERT GMBH
Date Cleared
2001-06-06
(162 days)
Product Code
BXN
Regulation Number
868.2775Why did this record match?
Applicant Name (Manufacturer) :
STOCKERT GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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