(175 days)
No
The document describes standard electrical stimulation devices with programmable settings, but there is no mention of AI or ML capabilities for adapting treatment or analyzing patient data.
Yes
The device is intended to provide symptomatic relief of pain, relax muscle spasms, prevent disuse atrophy, and improve gait for partially paralyzed patients, which are all therapeutic functions.
No
The document describes the device as a neuromuscular stimulator for treatment and relief of various conditions, not for diagnosis. Its intended uses involve stimulating muscles to improve gait, reduce pain, relax spasms, and prevent disuse atrophy.
No
The device description explicitly states that these are "Neuromuscular Stimulators" and describes physical characteristics like output channels and current generation, indicating they are hardware devices that deliver electrical stimulation.
Based on the provided information, the Neurodyn Multiwave and Aussie Sport devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVDs analyze samples from the human body. The provided text describes devices that apply electrical stimulation to the body for therapeutic purposes (muscle stimulation, pain relief). They do not analyze biological samples like blood, urine, or tissue.
- The intended uses are therapeutic. The indications for use clearly describe the application of electrical currents to treat conditions like muscle weakness, pain, and spasms. This is a therapeutic function, not a diagnostic one.
- The device description focuses on electrical stimulation parameters. The description details the types of electrical currents generated and their characteristics, which are relevant to therapeutic stimulation, not in vitro analysis.
Therefore, these devices fall under the category of therapeutic medical devices, not In Vitro Diagnostics.
N/A
Intended Use / 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
- 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 a range of motion
- Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
Product codes (comma separated list FDA assigned to the subject device)
IPF, GZJ, LIH, GZI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
muscles in the leg and ankle. Anatomical Sites: Identical (referring to predicate devices)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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 | Neurodyn
Multiwave | 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 the
muscles in the leg
and ankle of
partially
paralyzed
patients to | | As a FES device:
Stimulation of
muscles in the leg
and ankle of
partially paralyzed
patients to provide
flexion of the foot | As a FES device:
Stimulation of
muscles in the leg
and ankle of
partially paralyzed
patients to
provide flexion of | | |
3
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 of
the foot and thus
improve the
patient's gait. | and thus improve
the patient's gait. | 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 DC/Polarized
device:
Relaxation of
Muscle Spasm
As a Burst
Modulated
Alternating
Current -Russian
device:
Temporary
relaxation of | 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
pain, acute post
traumatic pain,
or acute post
traumatic
surgical pain
As a Burst
Modulated
Alternating
Current -Russian
device:
Temporary
relaxation of
muscle spasms | As a NMES device:
Retarding or
preventing disuse
atrophy
Maintaining or
increasing range
of motion
Reeducating
muscles
Relaxation of
muscle spasm
Increasing local
blood circulation
Prevention of
venous thrombosis
of the calf muscles
immediately after
surgery
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 This
device is not been
used as a
predicate for the
Interferential
waveform | 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 DC/ Mode
device:
Relaxation of
Muscle Spasm
As a Burst
Modulated
Alternating
Current -Russian
device:
Temporary
relaxation of | | | | | | |
| muscle spasms
Prevention or
retardation of
disuse atrophy in
post-injury type
conditions
Increase local
blood circulation
Muscle re- | device:
Symptomatic
relief of chronic
intractable pain,
acute post
traumatic pain, or
acute post
traumatic surgical
pain | Prevention or
retardation of
disuse atrophy in
post-injury type
conditions
Increase local
blood circulation
Muscle re- | device:
Symptomatic
relief of chronic
pain, acute post
traumatic pain, or
acute post
traumatic
surgical pain | | used as a
predicate for the
Interferential
waveform | muscle spasms
Prevention or
retardation of
disuse atrophy in
post-injury type
conditions
Increase local
blood circulation
Muscle re- | device:
Symptomatic
relief of chronic
intractable pain,
acute post
traumatic pain, or
acute post
traumatic surgical
pain | | |
| As a DC/Polarized
device:
Relaxation of
Muscle Spasm | | | As a DC/ Mode
device:
Relaxation of
Muscle Spasm | | | | | | |
| As a Burst
Modulated
Alternating
Current -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 | As a Burst
Modulated
Alternating
Current -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 | | As a Burst
Modulated
Alternating
Current -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 | | | | | | |
4
Image /page/4/Picture/0 description: The image shows the word "IBRAMED" in a bold, sans-serif font. Above the word is a symbol that looks like a stylized "I" with horizontal lines extending from the top and bottom. The symbol and the word are both in black, and the background is white. The image is a logo or brand mark.
:
·
| | Maintaining or
increasing range
of motion | Maintaining or
increasing range
of motion | | Maintaining or
increasing range
of motion | | Maintaining or
increasing range
of motion | | | | | | | |
|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------|----------------------------------------------------------------------------------------|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--|-----|--|-----|--|-----|--|
| | As an Burst
Modulated
Alternating
Current (Aussie)
device: | As a Burst
Modulated
Alternating
Current (Aussie)
device: | | As a Burst
Modulated
Alternating
Current (Aussie)
device: | | As an Burst
Modulated
Alternating
Current (Aussie
device: | | | | | | | |
| | Temporary
relaxation of
muscle spasms | Temporary
relaxation of
muscle spasms | | Temporary
relaxation of
muscle spasms | | Temporary
relaxation of
muscle spasms | | | | | | | |
| | Prevention or
retardation of
disuse atrophy in
post-injury type
conditions | Prevention or
retardation of
disuse atrophy in
post-injury type
conditions | | Prevention or
retardation of
disuse atrophy in
post-injury type
conditions | | Prevention or
retardation of
disuse atrophy in
post-injury type
conditions | | | | | | | |
| | Increase local
blood circulation | Increase local
blood circulation | | Increase local
blood circulation | | Increase local
blood circulation | | | | | | | |
| | Muscle re-
education | Muscle re-
education | | Muscle re-
education | | Muscle re-
education | | | | | | | |
| | Maintaining or
increasing range
of motion | | | | | Maintaining or
increasing range
of motion | | | | | | | |
| | Symptomatic
relief of chronic
intractable pain,
acute post
traumatic pain, or
acute post
traumatic surgical
pain | | | | | 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 | As a Microcurrent
device:
Symptomatic
relief of chronic
intractable pain | | As a Microcurrent
device:
Symptomatic
relief of chronic
intractable pain | | As a Microcurrent
device:
Symptomatic
relief of chronic
intractable pain | | | | | | | |
| | Symptomatic
relief of post-
traumatic acute
pain and post
surgical pain | Symptomatic
relief of post-
traumatic acute
pain and post
surgical pain | | Symptomatic
relief of post-
traumatic acute
pain and post
surgical pain | | Symptomatic
relief of post-
traumatic acute
pain and post
surgical pain | | | | | | | |
| Technological
characteristics
Medium-frequency
alternating current
(MFAC) | Identical | Identical | Identical | Identical | Identical | Identical | | | | | | | |
| Device Material | ABS plastic panel
LCD display | ABS plastic panel
LCD display | ABS plastic panel
LCD display | ABS plastic panel
LCD display | ABS plastic panel
LCD display | ABS plastic panel
LCD 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 of
Channels | 4 | 4 | 4 | 4 | 4 | 4 | | | | | | | |
| Temperature
range during
transport and
storage | 45°f-110°f | 45°f-110°f | -40 to 158°F | -40 to 150 F | 45°f-110°f | 45°f-110°f | | | | | | | |
| Environment
operating | 45°F-110°F | 45°F-110°F | 50° to 104°F | 45 to 105° F | 45°F-110°F | 45°F-110°F | | | | | | | |
.
5
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 cleared | |||||
| electrodes | FDA cleared | |||||
| electrodes | FDA cleared | |||||
| electrodes | FDA cleared | |||||
| electrodes | FDA cleared | |||||
| electrodes | FDA cleared | |||||
| electrodes | ||||||
| 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 | 100/240V | |||||
| 50/60Hz | ||||||
| Bivolt | 100/240V | |||||
| 50/60Hz | ||||||
| Bivolt | 3.0V DC | 100/240V | ||||
| 50/60Hz | ||||||
| 1.0A | 100/240V | |||||
| 50/60Hz | ||||||
| Bivolt | 100/240V | |||||
| 50/60Hz | ||||||
| Bivolt | ||||||
| Output | 5A+17V | 5A+17V | 1.0A+3.0V DC | 7.3A+24V | 5A+17V | 5A+17V |
| Method of line | ||||||
| current isolation | Double Isolation | Double Isolation | Double Isolation | Double Isolation | Double Isolation | Double Isolation |
| Patient leakage | ||||||
| control-normal | ||||||
| condition | 0.0508mA | 0.0508mA | 0.0502mA | 69μA | 0.0508mA | 0.0508mA |
| Patient leakage | ||||||
| current-single | ||||||
| fault condition | 0.0252mA | 0.0252mA | 0.0248mA | 31μA | 0.0252mA | 0.0252mA |
| Software | ||||||
| microprocessor | Yes | Yes | Yes | Yes | Yes | Yes |
| Automatic | ||||||
| overload trip | No | No | No | No | No | No |
| Automatic shutoff | No | No | No | No | No | No |
| Locking feature | Keyboard lock | |||||
| safety feature | Keyboard lock | |||||
| safety feature | Keyboard lock | |||||
| safety feature | Keyboard lock | |||||
| safety feature | Keyboard lock | |||||
| safety feature | Keyboard lock | |||||
| safety 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 and | ||||||
| repeat | Treatment timer | |||||
| with auto shut off | Treatment timer | |||||
| with auto shut off | Treatment timer | Treatment timer | ||||
| with auto shut off | Treatment timer | |||||
| with auto shut off | Treatment time | |||||
| with auto shut off | ||||||
| Frequency Range | 50/60Hz | 50/60Hz | --- | 50/60Hz | 50/60Hz | 50/60Hz |
| Maximum Current | ||||||
| Density | 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.
6
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
8
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 -
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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
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