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510(k) Data Aggregation
K Number
K210572Device Name
Neurodyn V2.0, Neurodyn Aussie V2.0
Manufacturer
Ibramed Equipamentos Medicos
Date Cleared
2021-05-11
(74 days)
Product Code
IPF
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Ibramed Equipamentos Medicos
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Neurodyn V2.0 Stimulators are intended for:
As a FES device:
- Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait.
As a TENS device:
- Symptomatic relief of chronic (long term) intractable pain
- Symptomatic relief of post-traumatic acute pain and post-surgical pain
As an Interferential and Premodulated device:
- Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
As a Russian device:
- Temporary relaxation of muscle spasms - Prevention of disuse atrophy in post-injury type conditions -Increase local blood circulation - Muscle re-education
- Maintaining or increasing range of motion
As a Burst Modulated Alternating Current (Aussie) device:
- Temporary relaxation of muscle spasms
- Prevention or retardation of disuse atrophy in post-injury type conditions
- Increase local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
As a Microcurrent device:
- Symptomatic relief of chronic intractable pain - Symptomatic relief of post-traumatic acute pain
As a DC/Polarized device: -Relaxation of Muscle Spasm
As a High Voltage Pulsed current device:
- Muscle re-education
- Relaxation of Muscle Spasms
- Maintaining or increasing range of motion
- Increasing local blood circulation
- Prevention or retardation of disuse atrophy
Neurodyn Aussie V2.0 Stimulators are intended for:
As a Burst Modulated Alternating Current (Aussie) device:
- Temporary relaxation of muscle spasms
- Prevention or retardation of disuse atrophy in post-injury type conditions
- Increase local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
Device Description
NEURODYN v2.0 is a transcutaneous neuromuscular stimulator of four channels with independent controls for treatments with: AUSSIE CURRENT (with Medium Frequency Current modulated in Burst), RUSSIAN CURRENT (Medium Frequency Current modulated in Burst), FES CURRENT (Functional Electrical Stimulation),TENS CURRENT(Transcutaneous Electrical Nerve Stimulation), INTERFERENTIAL CURRENT (IFC-T), PREMODULATED INTERFERENTIAL CURRENT (IFC-B) BIPOLAR (Medium Frequency Current modulated in Amplitude), and with two independent control channels for the treatments with: MICROCURRENT (Microcurrent Electrical Neuromuscular Stimulation), DIRECT CURRENT /POLARIZED CURRENT and HIGH VOLTAGE PULSED CURRENT (High Volt Pulsed Current).
NEURODYN AUSSIE V2.0 transcutaneous neuromuscular stimulator is a four-channel stimulator with independent controls for current therapy used in AUSSIE CURRENT (Burst Modulated Medium Frequency).
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K Number
K131926Device Name
THERMOPULSE
Manufacturer
IBRAMED EQUIPAMENTOS MEDICOS
Date Cleared
2014-07-24
(393 days)
Product Code
IMJ
Regulation Number
890.5290Why did this record match?
Applicant Name (Manufacturer) :
IBRAMED EQUIPAMENTOS MEDICOS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K131917Device Name
NEURODYN COMPACT, NEURODYN II
Manufacturer
IBRAMED EQUIPAMENTOS MEDICOS
Date Cleared
2014-04-29
(307 days)
Product Code
IPF, GZI, GZJ
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
IBRAMED EQUIPAMENTOS MEDICOS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for FES waveform:
- Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait.
Indications for TENS waveform:
- Symptomatic relief of chronic (long term) intractable pain
- Symptomatic relief of post-traumatic acute pain and post surgical pain
Indications for Russian waveform:
- Temporary relaxation of muscle spasms
- Prevention or retardation of disuse atrophy in post-injury type conditions
- Increase local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
Device Description
The device NEURODYN II is a four output channel stimulator, operated in power supply 100 to 240 V, 50-60 Hz, with independent controls, graphic display backlit blue, mechanical contact keyboard and ABS cabinet with acrylic cover.
Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation) FES (Functional Electrical Stimulation) RUSSIAN CURRENT (Burst Modulated Medium Frequency)
Characteristics:
TENS: four 120mA peak to peak channels FES: four 120mA peak to peak channels RUSSIAN: four 120mA peak to peak channels Electrical Feed: 100 a 240V (50/60Hz) Input Power: 85VA Temperature Range During Transport and Storage: 41 to 122°F Environment Operating Temperature Range: 41 to 113°F
The device NEURODYN COMPACT is a two output channel stimulator. operated in power supply 100 to 240 V, 50-60 Hz, with independent controls, graphic display backlit blue, mechanical contact keyboard and ABS cabinet with acrylic cover.
Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation) FES (Functional Electrical Stimulation) RUSSIAN CURRENT (Burst Modulated Medium Frequency)
Characteristics:
TENS: four 120mA peak to peak channels FES: four 120mA peak to peak channels RUSSIAN: four 120mA peak to peak channels Electrical Feed: 100 a 240V (50/60Hz) Input Power: 85VA Temperature Range During Transport and Storage: 41 to 122°F Environment Operating Temperature Range: 41 to 113°F
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K Number
K131309Device Name
SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ
Manufacturer
IBRAMED EQUIPAMENTOS MEDICOS
Date Cleared
2014-01-27
(265 days)
Product Code
IMI, CLA
Regulation Number
890.5300Why did this record match?
Applicant Name (Manufacturer) :
IBRAMED EQUIPAMENTOS MEDICOS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Therapeutic Ultrasound:
- Pain relief .
- . Reduction of muscle spasms
- Localized increase in blood flow .
- Increase range of motion of contracted joints using heat and stretch techniques .
Device Description
The Sonopulse Compact 1MHz is a therapeutic ultrasound device with a frequency of 1 MHz using a 7cm² transducer. The membrane panel provides both tactile and audio feedback when buttons are pressed. A guide provides a through set-up routine for the operator. The display will show which treatment has been chosen and when the output is active.
The Sonopulse Compact 3MHz is a therapeutic ultrasound device with a frequency of 3 MHz using a 7cm² transducer. The membrane panel provides both tactile and audio feedback when buttons are pressed. A guide provides a through set-up routine for the operator. The display will show which treatment has been chosen and when the output is active.
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K Number
K131629Device Name
NEURODYN MULTIWAVE, AUSSIE SPORT
Manufacturer
IBRAMED EQUIPAMENTOS MEDICOS
Date Cleared
2013-11-26
(175 days)
Product Code
IPF, GZI, GZJ, LIH
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
IBRAMED EQUIPAMENTOS MEDICOS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Neurodyn Multiwave - Indications for Use:
As a FES device:
- Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait.
As a TENS device:
- Symptomatic relief of chronic (long term) intractable pain
- Symptomatic relief of post-traumatic acute pain and post-surgical pain
As an Interferential and Premodulated device:
- Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
As a Russian device:
- Temporary relaxation of muscle spasms
- Prevention or retardation of disuse atrophy in post-injury type conditions
- Increase local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
As a Burst Modulated Alternating Current (Aussie) device:
- Temporary relaxation of muscle spasms
- Prevention or retardation of disuse atrophy in post-injury type conditions
- Increase local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
As a Microcurrent device:
- Symptomatic relief of chronic intractable pain
- Symptomatic relief of post-traumatic acute pain and post surgical pain
As a DC/Polarized device:
- Relaxation of Muscle Spasm
Aussie Sport - Indications for Use:
As an Burst Modulated Alternating Current (Aussie) device:
- Temporary relaxation of muscle spasms
- Prevention or retardation of disuse atrophy in post-injury type conditions
- Increase local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
Device Description
Neurodyn Multiwave and Aussie Sport Neuromuscular Stimulators are intended for the treatment of, relief of chronic (long term) intractable pain as adjunctive treatment of post-surgical and post-traumatic acute pain. Both devices have the same intended uses and incorporate the same technologies as the following predicate devices: Vectra Genisys K031077, Neurodyn/Neurpdun Aussie K121369 and 400PV Complete K021100.
The Neurodyn Multiwave Muscle Stimulator is a programmable device. It comes equipped with 5 preset clinical programs along with 10 user programs are adjustable and can be changed according to the patient's needs, doctor's recommendations and prescription settings.
The Aussie Sport Muscle Stimulator has four output channels with independent intensity controls. Thus, four different areas can be stimulated separately or together during a therapy session. It is adjustable and can be changed according to the patient's needs, doctor's recommendations and prescription settings. It generates the medium frequency alternate current(MFAC), burst modulated alternating current (Aussie)- type of sinusoidal current with a frequency carrying 1,000 Hz or 4,000 Hz and a burst duration of 4 ms or 2 ms, modulated in pulse trains (bursts) with a variable frequency from 1 to 120Hz.
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K Number
K121369Device Name
NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR
Manufacturer
IBRAMED EQUIPAMENTOS MEDICOS
Date Cleared
2012-12-19
(226 days)
Product Code
GZJ, GZI, IPF, LIH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
IBRAMED EQUIPAMENTOS MEDICOS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
As a TENS device:
Symptomatic relief of chronic (long term) intractable pain
Symptomatic relief of post-traumatic acute pain and post-surgical acute pain
As an Interferential and Premodulated device:
Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain
As a Russian device:
Temporary relaxation of muscle spasms
Prevention or retardation of disuse atrophy in post-injury type conditions
Increase local blood circulation
Muscle re-education
Maintaining or increasing range of motion
As an Burst modulated alternaing current (Aussie) device:
Temporary relaxation of muscle spasms
Prevention or retardation of disuse atrophy in post-injury type conditions
Increase local blood circulation
Muscle re-education
Maintaining or increasing range of motion
As a Microcurrent device:
Symptomatic relief of chronic intractable pain
Symptomatic relief of post-traumatic acute pain and post-surgical acute pain
Device Description
Neurodyn and Neurodyn Aussie Neuromuscular Stimulators are intended for the treatment of, relief of chronic (long term) intractable pain as adjunctive treatment of post-surgical and post-traumatic acute pain. Both devices have the same intended uses and incorporate the same technologies as the predicate the Vectra Genisys K031077. The Neurodyn Muscle Stimulator is a programmable device. It comes equipped with 5 preset clinical programs along with 10 user protocols. The user programs are adjustable and can be changed according to the patient's needs, doctor's recommendations and prescription settings.
The Neurodyn Aussie Muscle Stimulator has four output channels with independent intensity controls. Thus, four different areas can be stimulated separately or together during a therapy session. It is adjustable and can be changed according to the patient's needs, doctor's recommendations and prescription settings. It generates the medium frequency alternate current (MFAC), burst modulated alternating current (Aussie)- type of sinusoidal current with a frequency carrying 1,000 Hz or 4,000 Hz and a burst duration of 4 ms or 2 ms, modulated in pulse trains (bursts) with a variable frequency from 1 to 120Hz.
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