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510(k) Data Aggregation
K Number
K152571Device Name
Stivax
Manufacturer
BIEGLER GMBH
Date Cleared
2016-05-26
(260 days)
Product Code
BWK
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BIEGLER GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Stivax is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Device Description
The Stivax is a single use, battery-powered, electrical nerve stimulator which is used for the stimulation of the vagus nerve via the ear. The device connects an electrode cable to two sterile (radiation) acupuncture needles that have been applied by a healthcare practitioner. The stimulator connects to a clip holder on medical grade adhesive tape. The stimulator (with tape) adheres to the patient, behind the ear.
The STIVAX and the sterile (radiation) stimulation double needle are intended for single use.
The device consists of the stimulator and a stimulation double needle. The device cannot be recharged. The device has no connection to any external devices except the electrode.
The stimulator is housed in plastic. It is connected through a plug to the stimulation double needle (needles made of titanium, insulated wire). The power is supplied by a 3 V battery (type CR1220).
The dimensions of the device are W x H x D 34 x 7 x 20 mm, the weight is 4.41 g with battery.
The device is activated by connecting the stimulation double needle.
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K Number
K140788Device Name
P-STIM
Manufacturer
BIEGLER GMBH
Date Cleared
2014-06-27
(88 days)
Product Code
BWK
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BIEGLER GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
P-Stim is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Device Description
P-Stim is an electro-acupuncture device
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K Number
K121198Device Name
BW685, BW685S
Manufacturer
BIEGLER GMBH
Date Cleared
2012-07-12
(84 days)
Product Code
LGZ
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
BIEGLER GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BW685/BW685 S blood / fluid warming system is intended to deliver warm blood, blood products, and liquids to adult and pediatric patients.
Device Description
The BW685 and BW685S are blood and infusion fluid warmers designed to reduce complications associated with the infusion of blood or other liquids. They warm the fluid by means of an aluminum heat exchanger which is adjacent to an I.V. extension set through which the liquid to be heated flows. The electrically powered heat exchanger has a spiral groove through which the I.V. extension set is wrapped. There is no direct contact between the heat exchanger and infusate, the infusate only contacts the I.V. extension set. The BW685 and BW685S operate on 120 VAC and are controlled by an on-off switch on the plastic face of the instrument. Above the on-off switch is an LED indicator which indicates the temperature setting as well as the measured temperature. The set temperature is selectable in increments of 0.5° C between 37 and 41°C. The default temperature is 38.5° C. The infusate is warmed to approximately the set temperature as it travels a path around the constantly monitored and regulated heat exchanger. The temperature is measured at the end of the extension set, where it leaves the spiral groove. The BW685 / BW685 S weigh 1.9 and 2.0 kg respectively and are equipped with a dual knob clamp at the back of the devices for attachment to an I.V. pole; the devices may also be clamped to a bedrail. The BW685 and BW685S are identical except that the BW685 S has provision and additional circuitry for connection to an additional heating element that can be placed nearer the patient. The additional heating element is called the TubeFlow and fits over the I.V. line to the patient. The TubeFlow is electrically powered from the BW685S and contains a display indicative of the heating status (green for heating) or over-temperature (red). The TubeFlow does not contain software.
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