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Found 19 results
510(k) Data Aggregation
K Number
K244030Device Name
Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)
Manufacturer
Wuxi Jiajian Medical Instrument Co., Ltd.
Date Cleared
2025-03-28
(88 days)
Product Code
BWK
Regulation Number
N/AWhy did this record match?
Product Code :
BWK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Device Description
Needle Stimulator is an electro-acupuncture device for acupuncture therapy, powered by 6 pieces of 1.5V batteries or AC 100-240V. It is composed of a console and 6 channels of electrode cables with alligator type connectors. The console has the operating controls including function knobs or buttons. Needle Stimulator does not equip with acupuncture needles. The practitioners should select legally marketed needles.
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K Number
K220153Device Name
Needle Stimulator (Model: RJNS6-1)
Manufacturer
Bozhou Rongjian Medical Appliance Co.,Ltd.
Date Cleared
2022-03-18
(58 days)
Product Code
BWK
Regulation Number
N/AWhy did this record match?
Product Code :
BWK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Needle Stimulator (Model: RJNS6-1) is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Device Description
Needle Stimulator (Model: RJNS6-1) is an electro-acupuncture device for acupuncture therapy, powered by 6 pieces of 1.5V batteries or AC 100-240V. It is composed of a LCD, a console and 6 channels of electrode cables with alligator type connectors. Only 3 channels at most could work together on single patient. The console has the operating elements of Channel selecting button, Setting button, Operation suspending switch button, Wave-selecting button, On/off switch, Mute button, Therapy time adjusting button, Output frequency adjusting button, Intensity adjust knobs, and Output indicator light. Needle Stimulator (Model: RJNS6-1) does not equip with acupuncture needles. The practitioners should select 510(k) cleared needles (with minimum diameter of 0.40mm and insertion depth of 16mm) for use.
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K Number
K202861Device Name
Needle Stimulator
Manufacturer
Wuxi Jiajian Medical Instrument Co., Ltd
Date Cleared
2021-08-27
(333 days)
Product Code
BWK
Regulation Number
N/AWhy did this record match?
Product Code :
BWK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Device Description
Needle Stimulator is an electro-acupuncture device for acupuncture therapy powered by 6 pieces of 1.5V batteries or AC 100-240V. It is composed of a console and 6 channels of electrode cables with alligator type connectors. The console has the operating controls including function knobs or buttons. Needle Stimulator does not equip with acupuncture needles. The practitioners should select legally marketed needles.
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K Number
K200636Device Name
AXUS ES-5 Electro-Acupuncture Device
Manufacturer
Lhasa OMS, INC.
Date Cleared
2021-02-03
(330 days)
Product Code
BWK
Regulation Number
N/AWhy did this record match?
Product Code :
BWK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AXUS ES-5 Electro Acupuncture Device is an electro-acupuncture device indicated for use in the practice of acupuncture by qualified professionals of acupuncture as determined by the states.
Device Description
The AXUS ES-5 is an electro-acupuncture device indicated for use in the practice of acupuncture by qualified professionals of acupuncture as determined by the state. The AXUS ES-5 is a battery operated prescription use only electro-acupuncture device used for applying electric stimuli to areas of preferred delivery (APD). The device uses a low-intensity, low-frequency pulse multimode generator through microalligator clips attached to commercially available and FDA-cleared stainless steel acupuncture needles. The device can also deliver stimulation with the included probe.
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K Number
K170391Device Name
ANSiStim-PP
Manufacturer
DyAnsys Inc
Date Cleared
2017-03-09
(29 days)
Product Code
BWK
Regulation Number
N/AWhy did this record match?
Product Code :
BWK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ANSiStim-PP 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 ANSiStim®-PP is a wearable, battery-operated device that is designed to administer continuous low-level electrical pulses to the ear over four days / 96 hours from the time of activation of the device. The electrical pulse from the device will be delivered to the stimulation point on the ear through a set of wire assembly and Stimulation needles. Three zinc air batteries with 1.4 V each provides the required stimulation energy for a maximum of 96 hours. There are three Stimulation needles and one ground electrode - which constitute of a needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the auricular cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device is also provided with a bottom ground.
There are three options available for using the ground terminal in the device. Either the ground electrode or the bottom ground can be used. Or both the ground electrode and bottom ground can be used together.
This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The treatment period varies based on the severity of the pain in the individual.
The stimulation pattern consists of 1 Hz single pulses with square waveform. The current direction is inverted every second pulse, which is intended to avoid polarization effects. To minimize the risk of adaption or tolerance to the electrical stimulation is applied for 3 hours, followed by a pause of 3 hours.
A 3-pin connector is provided, which is used to check the output voltage of the device once it is activated and before applying to the patient with any one of the voltage measuring devices available in the market with the appropriate regulatory compliance.
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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?
Product Code :
BWK
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
K141168Device Name
ANSISTIM
Manufacturer
DYANSYS, INC.
Date Cleared
2015-05-15
(374 days)
Product Code
BWK
Regulation Number
N/AWhy did this record match?
Product Code :
BWK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ANSiStim™ 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 ANSiStim™ is a wearable battery-operated device that is designed to administer continuous low-level electrical pulses at the ear over four days. The stimulation needles are inserted at three specific points, which have the ability to stimulate the acupoints in the human body. Three zinc air batteries with 1.4 V provide the required stimulation energy for a maximum of 96 hours. This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The stimulation pattern consists of 1 Hz single pulses with square waveform. The current direction is inverted every second pulse, which is intended to avoid polarization effects. To minimize the risk of adaption or tolerance to the electrical stimulation, stimulation is applied for 3 hours, followed by a pause of 3 hours.
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K Number
K133980Device Name
PANTHEON ELECTROSTIMULATOR
Manufacturer
PANTHEON RESEARCH
Date Cleared
2014-11-07
(315 days)
Product Code
BWK
Regulation Number
N/AWhy did this record match?
Product Code :
BWK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pantheon Research Electrostimulator 4c.Pro, 8c.Pro, 12c.Pro, & 9c3i are for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Device Description
The Pantheon Research Pro Series electro-acupuncture stimulators are electrical stimulators that introduce calibrated and controlled electrical impulses into acupuncture needles inserted into patients for therapeutic purposes. These devices are built in 5 models: the 4c.Pro. 6c.Pro. 12c.Pro. and 9c3i models. The Pantheon electro-acupuncture stimulator series does not come equipped with acupuncture needles. The practitioners should select 510(k) cleared needles
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K Number
K140530Device Name
Electro Auricular Device
Manufacturer
NAVIGANT CONSULTING, INC.
Date Cleared
2014-10-02
(212 days)
Product Code
BWK
Regulation Number
N/AWhy did this record match?
Product Code :
BWK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EAD 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 EAD system is a battery-operated, single-use device that has a preprogrammed frequency, pulse and duration for the stimulation of auricular point nerve stimulation for pain. The device power supply connects via four (4) stainless steel wires, sheathed in a plastic over-molding, to three (3) needle arrays comprised of four (4) needles each and one (1) needle array comprised of only 1 needle.
The device is powered by one 3 Volt lithium ion battery.
The device modulates a duty cycle between 2 hours on and 2 hours at rest. The maximum performance time frame is 5 days or 120 hours (5 days X 24 hours). Weight is 4 grams including batteries. The power supply dimensions are 36 mm x 17 mm x 7 mm. The needle dimensions are 0.5 mm width x 2 mm length.
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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?
Product Code :
BWK
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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