(175 days)
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
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.
The provided document is a 510(k) Summary for the Neurodyn Multiwave and Aussie Sport powered muscle stimulators. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a study with specific acceptance criteria and performance metrics for the device itself.
Therefore, the following information cannot be extracted from the document:
- A table of acceptance criteria and the reported device performance: The document does not define specific performance acceptance criteria for the Neurodyn Multiwave or Aussie Sport devices, nor does it report their performance against such criteria. Instead, it relies on demonstrating that the device characteristics are "identical" to predicate devices.
- Sample size used for the test set and the data provenance: No test set or associated data provenance is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No experts or ground truth establishment are discussed.
- Adjudication method for the test set: No adjudication method is mentioned as there is no test set described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, an effect size of how much human readers improve with AI vs without AI assistance: No MRMC study or AI assistance is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance is discussed.
- The type of ground truth used: No ground truth is specified.
- The sample size for the training set: No training set is mentioned.
- How the ground truth for the training set was established: No training set or ground truth establishment is discussed.
Summary of Device Comparison (as provided in the document - not an acceptance criteria table):
The document provides a "Device Comparison Table" to show substantial equivalence, not to present acceptance criteria and performance. The key points from this table are:
| Feature/Criterion | Neurodyn Multiwave (K131629, New Device) | Predicate Devices (Neurodyn K121369, 300 PV K021100, Vectra Genisys K031077) & Aussie Sport (K131629, New Device) |
|---|---|---|
| Technological characteristics | Identical | Identical (Medium-frequency alternating current - MFAC) |
| Device Material | ABS plastic panel, LCD display | ABS plastic panel, LCD display |
| Width (in) | 6.8 | Varied (6.8, 9.75, 1.26) |
| Height (in) | 4.9 | Varied (4.9, 3.3, 8.75) |
| Depth (in) | 12.4 | Varied (12.4, 12.75, 4.5) |
| Number of Channels | 4 | 4 |
| Temperature range during transport and storage | 45°f-110°f | Varied (45°f-110°f, -40 to 158°F, -40 to 150 F) |
| Environment operating temperature range | 45°F-110°F | Varied (45°F-110°F, 50° to 104°F, 45 to 105° F) |
| Performance | Identical | Identical |
| Biocompatibility | FDA cleared electrodes | FDA cleared electrodes |
| Mechanical Safety | Identical | Identical |
| Anatomical Sites | Identical | Identical |
| Russian Current | Yes | Yes (Neurodyn, Vectra Genisys); No (300 PV, Aussie Sport) |
| Aussie Current | Yes | Yes (Neurodyn, Vectra Genisys, Aussie Sport) |
| Interferential Current | Yes | Yes (Neurodyn, 300 PV, Vectra Genisys); No (Aussie Sport) |
| Microcurrent | Yes | Yes (Neurodyn, Vectra Genisys); No (300 PV, Aussie Sport) |
| TENS | Yes | Yes (Neurodyn, 300 PV, Vectra Genisys); No (Aussie Sport) |
| Premodulated | Yes | Yes (Neurodyn, 300 PV, Vectra Genisys); No (Aussie Sport) |
| FES | Yes | Yes (300 PV, Vectra Genisys); No (Neurodyn, Aussie Sport) |
| DC/Polarized | Yes | Yes (Vectra Genisys); No (Neurodyn, 300 PV, Aussie Sport) |
| Voltage Input | 100/240V 50/60Hz Bivolt | Varied (100/240V 50/60Hz Bivolt, 3.0V DC, 100/240V 50/60Hz 1.0A) |
| Output | 5A+17V | Varied (5A+17V, 1.0A+3.0V DC, 7.3A+24V) |
| Method of line current isolation | Double Isolation | Double Isolation |
| Patient leakage control (normal condition) | 0.0508mA | Varied (0.0508mA, 0.0502mA, 69μA) |
| Patient leakage current (single fault condition) | 0.0252mA | Varied (0.0252mA, 0.0248mA, 31μA) |
| Software microprocessor | Yes | Yes |
| Automatic overload trip | No | No |
| Automatic shutoff | No | No |
| Locking feature | Keyboard lock safety feature | Keyboard lock safety feature |
| Treatment timer | 1 to 60 minutes | Varied (1 to 60 minutes, 5 to 60 minutes) |
| Auto test and repeat | Treatment timer with auto shut off | Treatment timer with auto shut off / Treatment timer |
| Frequency Range | 50/60Hz | Varied (50/60Hz, ---) |
| Maximum Current Density | 2.0 mA | 2.0 mA |
Conclusion: The 510(k) summary concludes that the Neurodyn Muscle Stimulators are substantially equivalent to the predicate devices based on similarities in indications for use, technological design, materials, and various performance characteristics. The argument made is that because the new devices are "identical" or sufficiently similar to cleared predicate devices, they do not raise new issues of safety or effectiveness. No specific study demonstrating the new device's performance against defined acceptance criteria is presented.
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Image /page/0/Picture/0 description: The image shows a logo for IBRAMED. The logo consists of a stylized symbol above the word "IBRAMED" in a bold, sans-serif font. The symbol is composed of three horizontal bars on the top and bottom, connected by a vertical bar in the center, creating a symmetrical design. The entire logo is in black against a white background.
SECTION 6
510(k) Summary
Neurodyn Multiwave
510 (k) Number: K131629
Date of Submission: November 25, 2013
Submitter:
IBRAMED EQUIPAMENTOS MEDICOS Avenida Dr. Carlos Burgos 2800 Amparo - Sao Paulo - Brasil
TEL - 5519-3817-9633 FAX - 5519-7816-7980
Official Contact:
Lilian Llull TechLink International Consulting 18851 NE 29th Avenue Suite 720 Aventura, FL 33180
TEL - (305) 377-0077
This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510 (k) premarket notification is in accordance with 21 CFR 807.87.
Common (Standard) Name: Powered Muscle Stimulator Neurodyn Multiwave; Aussie Sport Trade Name:
Regulation Number & Product Codes:
GZJ - 21 CFR 882.5890-Transcutaneous electrical nerve stimulator for pain relief
- IPF 21 CFR 890.5850-Powered muscle stimulator
- LIH Interferential Current Therapy-Pre-amendment
- GZI- 21 CFR 882.5890-External functional neuromuscular stimulator
Predicate Device Identification:
K121369 Neurodyn/Neurodyn Aussie Powered Muscle Stimulator K021100 300 PV Complete Electrotherapy K031077 Vectra Genisys
Predicate devices had been submitted and cleared by 510(k) for the same intended uses and
NOV 2 6 2013
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Image /page/1/Picture/0 description: The image shows a logo for IBRAMED. The logo consists of a stylized symbol above the word "IBRAMED". The symbol is composed of three horizontal bars connected by a vertical bar in the center, with the top and bottom bars having angled ends. Below the logo, the word "indications" is printed in a smaller font size.
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.
Indications for 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
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Image /page/2/Picture/0 description: The image shows a logo for IBRAMED. The logo consists of a stylized symbol above the word "IBRAMED" in a bold, serif font. The symbol is composed of horizontal bars connected by vertical lines, creating a geometric design. The overall impression is modern and professional.
-
ncrease 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
Essential Performance
Neurodyn Multiwave Muscle Stimulator produces the following currents: Russian/Aussie /Interferential /Tens /Premodulated / Microcurrent/FES/DC Polarized.
The Aussie Sport Muscle Stimulator produces an Aussie current.
Summary of Safety and Effectiveness Conclusion
The Neurodyn Muscle Stimulators are substantially to the predicate devices. All five devices claim similar Indications for Use and Device Characteristics in technological design and materials. The Neurodyn Muscle Stimulators do not raise any new issues of Safety and Effectiveness based on their similarities. The devices have continually proven to be safe and effective and demonstrate intended product performance.
Device Comparison Table
| Device name | NeurodynMultiwave | Neurodyn | 300 PV Empi | Vectra Genysis | Aussie Sport | Aussie |
|---|---|---|---|---|---|---|
| K Number | K131629 | K121369 | K021100 | K031077 | K131629 | K121369 |
| Manufacturer | Ibramed | Ibramed | Empi | Chattanooga | Ibramed | Ibramed |
| Indications for Use | As a FES device:Stimulation of themuscles in the legand ankle ofpartiallyparalyzedpatients to | As a FES device:Stimulation ofmuscles in the legand ankle ofpartially paralyzedpatients to provideflexion of the foot | As a FES device:Stimulation ofmuscles in the legand ankle ofpartially paralyzedpatients toprovide flexion of |
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Image /page/3/Picture/0 description: The image shows a logo for IBRAMED. The logo consists of a stylized "I" shape above the word "IBRAMED" in bold, block letters. The "I" shape is made up of several horizontal bars and triangles, creating a geometric design.
| provide flexion ofthe foot and thusimprove thepatient's gait. | and thus improvethe patient's gait. | the foot and thusimprove thepatient's gait. | |||||||
|---|---|---|---|---|---|---|---|---|---|
| As a TENSdevice:Symptomaticrelief of chronic(long term)intractable painSymptomaticrelief of post-traumatic acutepain and postsurgical painAs anInterferential andPremodulateddevice:Symptomaticrelief of chronicintractable pain,acute posttraumatic pain, oracute posttraumatic surgicalpainAs a DC/Polarizeddevice:Relaxation ofMuscle SpasmAs a BurstModulatedAlternatingCurrent -Russiandevice:Temporaryrelaxation of | As a TENSdevice:Symptomaticrelief of chronic(long term)intractable painSymptomaticrelief of post-traumatic acutepain and postsurgical painAs anInterferential andPremodulateddevice:Symptomaticrelief of chronicpain, acute posttraumatic pain,or acute posttraumaticsurgical painAs a BurstModulatedAlternatingCurrent -Russiandevice:Temporaryrelaxation ofmuscle spasms | As a NMES device:Retarding orpreventing disuseatrophyMaintaining orincreasing rangeof motionReeducatingmusclesRelaxation ofmuscle spasmIncreasing localblood circulationPrevention ofvenous thrombosisof the calf musclesimmediately aftersurgeryAs a TENS device:Symptomatic reliefof chronic (longterm) intractablepainSymptomatic reliefof post-traumaticacute pain andpost surgical painAs anInterferential Thisdevice is not beenused as apredicate for theInterferentialwaveform | As a TENS device:Symptomaticrelief of chronic(long term)intractable painSymptomaticrelief of post-traumatic acutepain and postsurgical painAs anInterferential andPremodulateddevice:Symptomaticrelief of chronicintractable pain,acute posttraumatic pain, oracute posttraumatic surgicalpainAs a DC/ Modedevice:Relaxation ofMuscle SpasmAs a BurstModulatedAlternatingCurrent -Russiandevice:Temporaryrelaxation of | ||||||
| muscle spasmsPrevention orretardation ofdisuse atrophy inpost-injury typeconditionsIncrease localblood circulationMuscle re- | device:Symptomaticrelief of chronicintractable pain,acute posttraumatic pain, oracute posttraumatic surgicalpain | Prevention orretardation ofdisuse atrophy inpost-injury typeconditionsIncrease localblood circulationMuscle re- | device:Symptomaticrelief of chronicpain, acute posttraumatic pain, oracute posttraumaticsurgical pain | used as apredicate for theInterferentialwaveform | muscle spasmsPrevention orretardation ofdisuse atrophy inpost-injury typeconditionsIncrease localblood circulationMuscle re- | device:Symptomaticrelief of chronicintractable pain,acute posttraumatic pain, oracute posttraumatic surgicalpain | |||
| As a DC/Polarizeddevice:Relaxation ofMuscle Spasm | As a DC/ Modedevice:Relaxation ofMuscle Spasm | ||||||||
| As a BurstModulatedAlternatingCurrent -Russiandevice:Temporaryrelaxation ofmuscle spasmsPrevention orretardation ofdisuse atrophy inpost-injury typeconditionsIncrease localblood circulationMuscle re-education | As a BurstModulatedAlternatingCurrent -Russiandevice:Temporaryrelaxation ofmuscle spasmsPrevention orretardation ofdisuse atrophy inpost-injury typeconditionsIncrease localblood circulationMuscle re-education | As a BurstModulatedAlternatingCurrent -Russiandevice:Temporaryrelaxation ofmuscle spasmsPrevention orretardation ofdisuse atrophy inpost-injury typeconditionsIncrease localblood circulationMuscle re-education |
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:
·
| Maintaining orincreasing rangeof motion | Maintaining orincreasing rangeof motion | Maintaining orincreasing rangeof motion | Maintaining orincreasing rangeof motion | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| As an BurstModulatedAlternatingCurrent (Aussie)device: | As a BurstModulatedAlternatingCurrent (Aussie)device: | As a BurstModulatedAlternatingCurrent (Aussie)device: | As an BurstModulatedAlternatingCurrent (Aussiedevice: | ||||||||||
| Temporaryrelaxation ofmuscle spasms | Temporaryrelaxation ofmuscle spasms | Temporaryrelaxation ofmuscle spasms | Temporaryrelaxation ofmuscle spasms | ||||||||||
| Prevention orretardation ofdisuse atrophy inpost-injury typeconditions | Prevention orretardation ofdisuse atrophy inpost-injury typeconditions | Prevention orretardation ofdisuse atrophy inpost-injury typeconditions | Prevention orretardation ofdisuse atrophy inpost-injury typeconditions | ||||||||||
| Increase localblood circulation | Increase localblood circulation | Increase localblood circulation | Increase localblood circulation | ||||||||||
| Muscle re-education | Muscle re-education | Muscle re-education | Muscle re-education | ||||||||||
| Maintaining orincreasing rangeof motion | Maintaining orincreasing rangeof motion | ||||||||||||
| Symptomaticrelief of chronicintractable pain,acute posttraumatic pain, oracute posttraumatic surgicalpain | Symptomaticrelief of chronicintractable pain,acute posttraumatic pain,or acute posttraumaticsurgical pain | ||||||||||||
| As a Microcurrentdevice:Symptomaticrelief of chronicintractable pain | As a Microcurrentdevice:Symptomaticrelief of chronicintractable pain | As a Microcurrentdevice:Symptomaticrelief of chronicintractable pain | As a Microcurrentdevice:Symptomaticrelief of chronicintractable pain | ||||||||||
| Symptomaticrelief of post-traumatic acutepain and postsurgical pain | Symptomaticrelief of post-traumatic acutepain and postsurgical pain | Symptomaticrelief of post-traumatic acutepain and postsurgical pain | Symptomaticrelief of post-traumatic acutepain and postsurgical pain | ||||||||||
| TechnologicalcharacteristicsMedium-frequencyalternating current(MFAC) | Identical | Identical | Identical | Identical | Identical | Identical | |||||||
| Device Material | ABS plastic panelLCD display | ABS plastic panelLCD display | ABS plastic panelLCD display | ABS plastic panelLCD display | ABS plastic panelLCD display | ABS plastic panelLCD display | |||||||
| Width (in) | 6.8 | 6.8 | 9.75 | 1.26 | 6.8 | 6.8 | |||||||
| Height | 4.9 | 4.9 | 8.75 | 3.3 | 4.9 | 4.9 | |||||||
| Depth | 12.4 | 12.4 | 12.75 | 4.5 | 12.4 | 12.4 | |||||||
| Number ofChannels | 4 | 4 | 4 | 4 | 4 | 4 | |||||||
| Temperaturerange duringtransport andstorage | 45°f-110°f | 45°f-110°f | -40 to 158°F | -40 to 150 F | 45°f-110°f | 45°f-110°f | |||||||
| Environmentoperating | 45°F-110°F | 45°F-110°F | 50° to 104°F | 45 to 105° F | 45°F-110°F | 45°F-110°F |
.
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Image /page/5/Picture/0 description: The image shows a logo for IBRAMED. The logo consists of a stylized symbol above the word "IBRAMED" in bold, block letters. The symbol is composed of horizontal bars and angled shapes, creating a geometric design. A horizontal line underlines the word "IBRAMED".
| temperature range | ||||||
|---|---|---|---|---|---|---|
| Performance | Identical | Identical | Identical | Identical | Identical | Identical |
| Biocompatibility | FDA clearedelectrodes | FDA clearedelectrodes | FDA clearedelectrodes | FDA clearedelectrodes | FDA clearedelectrodes | FDA clearedelectrodes |
| Mechanical Safety | Identical | Identical | Identical | Identical | Identical | Identical |
| Anatomical Sites | Identical | Identical | Identical | Identical | Identical | Identical |
| Russian | Yes | Yes | No | Yes | No | No |
| Aussie | Yes | Yes | No | Yes | Yes | Yes |
| Interferential | Yes | Yes | Yes | Yes | No | No |
| Microcurrent | Yes | Yes | No | Yes | No | No |
| TENS | Yes | Yes | Yes | Yes | No | No |
| Premodulated | Yes | Yes | Yes | Yes | No | No |
| FES | Yes | No | Yes | Yes | No | No |
| DC/Polarized | Yes | No | No | Yes | No | No |
| Voltage Input | 100/240V50/60HzBivolt | 100/240V50/60HzBivolt | 3.0V DC | 100/240V50/60Hz1.0A | 100/240V50/60HzBivolt | 100/240V50/60HzBivolt |
| Output | 5A+17V | 5A+17V | 1.0A+3.0V DC | 7.3A+24V | 5A+17V | 5A+17V |
| Method of linecurrent isolation | Double Isolation | Double Isolation | Double Isolation | Double Isolation | Double Isolation | Double Isolation |
| Patient leakagecontrol-normalcondition | 0.0508mA | 0.0508mA | 0.0502mA | 69μA | 0.0508mA | 0.0508mA |
| Patient leakagecurrent-singlefault condition | 0.0252mA | 0.0252mA | 0.0248mA | 31μA | 0.0252mA | 0.0252mA |
| Softwaremicroprocessor | Yes | Yes | Yes | Yes | Yes | Yes |
| Automaticoverload trip | No | No | No | No | No | No |
| Automatic shutoff | No | No | No | No | No | No |
| Locking feature | Keyboard locksafety feature | Keyboard locksafety feature | Keyboard locksafety feature | Keyboard locksafety feature | Keyboard locksafety feature | Keyboard locksafety feature |
| Treatment timer | 1 to 60 minutes | 1 to 60 minutes | 5 to 60 minutes | 1 to 60 minutes | 1 to 60 minutes | 1 to 60 minutes |
| Auto test andrepeat | Treatment timerwith auto shut off | Treatment timerwith auto shut off | Treatment timer | Treatment timerwith auto shut off | Treatment timerwith auto shut off | Treatment timewith auto shut off |
| Frequency Range | 50/60Hz | 50/60Hz | --- | 50/60Hz | 50/60Hz | 50/60Hz |
| Maximum CurrentDensity | 2.0 mA | 2.0 mA | 2.0 mA | 2.0 mA | 2.0 mA | 2.0 mA |
Conclusion
This premarket notification is being submitted to request clearance for the Neurodyn Muscle Stimulators. The analysis on the device demonstrates substantial equivalence to the Ibramed Neurodyn, Vectra Genisys, and EMPI 300 PV.
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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. To the left of the bird symbol is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 26, 2013
Ibramed Equipamentos Medicos c/o Ms. Lilian Llull Techlink International Consulting 18851 NE 29th Avenue Suite 720 Aventura, FL 33180
Re: K131629
Trade/Device Name: Neurodyn Multiwave and Aussie Sport Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ, LIH, GZI Dated: October 25, 2013 Received: October 28, 2013
Dear Ms. Llull:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
{7}------------------------------------------------
Page 2 - Ms. Lilian Llull
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K131629
Device Name: Neurodyn Multiwave and Aussie Sport
Indications For 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 ı
- Symptomatic relief of post-traumatic acute pain and post-surgical pain ー
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 l
-
Prevention or retardation of disuse atrophy in post-injury type conditions l
-
Increase local blood circulation l
-
Muscle re-education l
-
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 1
- Increase local blood circulation -
- l . Muscle re-education
- Maintaining or increasing range of motion l
- 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 r
- Symptomatic relief of post-traumatic acute pain and post-surgical pain -
Page 1 of 2
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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 u surgical pain
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) .
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M. Whang -S
Page 2 of 2
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).