NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR

K121369 · Ibramed Equipamentos Medicos · GZJ · Dec 19, 2012 · Neurology

Device Facts

• Record ID: K121369
• Device Name: NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR
• Applicant: Ibramed Equipamentos Medicos
• Product Code: GZJ · Neurology
• Decision Date: Dec 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

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 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 Story

Neurodyn and Neurodyn Aussie are programmable powered muscle stimulators used in clinical settings by healthcare providers. Devices deliver various electrical currents—Russian, Aussie (MFAC), Interferential, TENS, Premodulated, and Microcurrent—to patients via electrodes. Input parameters (intensity, frequency, burst duration) are adjusted based on patient needs and prescription settings. The Neurodyn features 5 preset clinical programs and 10 user-adjustable protocols; the Neurodyn Aussie provides four independent output channels. Devices utilize microprocessor control to manage treatment timers, automatic shut-off, and overload protection. Output affects muscle tissue or nerves to provide pain relief, muscle relaxation, or re-education. Benefits include improved circulation, atrophy prevention, and pain management. Healthcare providers monitor patient response and adjust intensity levels accordingly.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included electrical safety, electromagnetic compatibility (EMC), and performance verification against established standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10).

Technological Characteristics

Powered muscle stimulator; ABS plastic housing; LCD display. Delivers Russian, Aussie (MFAC), Interferential, TENS, Premodulated, and Microcurrent waveforms. 4 output channels with independent intensity control. Microprocessor-controlled. Connectivity: Standalone. Power: 100/240V Bivolt. Safety: Double isolation, Class II, Type BF. Electrodes: Axelgaard (K970426). Standards: NBR IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 13485.

Indications for Use

Indicated for patients requiring symptomatic relief of chronic intractable pain, post-traumatic acute pain, or post-surgical acute pain; temporary relaxation of muscle spasms; prevention or retardation of disuse atrophy; increase of local blood circulation; muscle re-education; and maintenance or increase of range of motion.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• Chattanooga Vectra Genisys (K031077)

Submission Summary (Full Text)

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### SECTION 9

## 510(k) Summary

Neurodyn Powered Muscle Stimulator Neurodyn Aussie Muscle Stimulator

510 (k) Number: K121369

Date of Submission December 13, 2012

### 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 - [phone] FAX - [phone]

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 |
|-------------------------|-------------------------------------------|
| Trade Name: | Neurodyn Powered Muscle Stimulator |
| | Neurodyn Aussie Powered Muscle Stimulator |

### 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 882.5810-External functional neuromuscular stimulator

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Specifications - Both devices were designed according to Existing Technical Standards for the Development of Medical Devices (NBR NBR IEC 60601-1 IEC 60601-1-2 and IEC 60601-2-10 NBR). Predicate Device Identification:

Chattanooga Vectra Genisys K031077

Predicate devices had been submitted and cleared by 510(k) for the same intended uses and indications.

## 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. ·

### Indications for 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

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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

## Essential Performance

Neurodyn Muscle Stimulator produces the following currents: Russian / Aussie / Interferential / Tens / Premodulated / Microcurrent

Neurodyn Aussie Muscle Stimulator produces the burst modulated alternating current (Aussie) medium frequency alternate current. The current intensity required for treatment depends on the patient's sensitivity. The treatment should be started with minimum levels of intensity .with gradual increase until the patient achieves the full effect of the treatment.

## Electrodes

Electrodes used are Axelgaard K970426. The minimal size of the electrode that can used with the Neurodyn and Neurodyn Aussie is 25cm².

# Patient Cables

Utilizes shrouded connectors to meet Lead Wire Connectors Safety Requirements IEC-60601-1 Sub clause 66-3 -c -according to 21 CFR 898. They are designed to be 4.5 feet (1.5 meters) away from the patient. The connector cables are designed to comply with subclause 56.3 ( c ) of the following standard: International Electrotechnical Commission (IEC) 60601-1: Medical Electrical Equipment 60601-1 (1988) Part 1: General requirements for safety Amendment No. 1 (1991) Amendment No. 2 (1995)

# Declaration of Conformity

This device has been assessed and found compliant. It upholds the highest safety and effectiveness standards.

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# Summary of Safety and Effectiveness

- The Neurodyn and Neurodyn Aussie Muscle Stimulators are substantially equivalent to the Vetra Genisys K031077 manufactured by Chattanooga. All three devices claim similar Indications for Use and Device Characteristics in technological design and materials.

- The Neurodyn and Neurodyn Aussie 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.

# Non-Clinical Tests Submitted:

The Ibramed Powered Muscle Stimulators have been tested in accordance with the applicable standards for medical device electrical safety, electromagnetic compatibility and the particular requirements for stimulator nerve and muscle safety.

| EMC<br>l | l est |
|----------|-------|
| | |

| Device Name | Neurodyn Aussie | Neurodyn | Vectra Genisys |
|-------------------------------------------------------|----------------------------------|----------------------------------|----------------------------------|
| K number | 121369 | 121369 | 031077 |
| Manufacturer | Ibramed | Ibramed | Ibramed |
| Intended use | Identical | Identical | Identical |
| Indications for use | Identical | Identical | Identical |
| Target population | Identical | Identical | Identical |
| Human factors | Identical | Identical | Identical |
| Contraindication | Identical | Identical | Identical |
| Device Name | Neurodyn Aussie | Neurodyn | Vectra Genisys |
| K number | --- | --- | K031077 |
| Manufacturer | Ibramed | Ibramed | Chattanooga |
| Technological<br>characteristics | Identical | Identical | Identical |
| Medium-<br>frequency<br>alternating current<br>(MFAC) | | | |
| Device Material | ABS plastic panel<br>LCD display | ABS plastic panel<br>LCD display | ABS plastic panel<br>LCD display |
| Width (in) | 10.6 | 14.6 | 9.75 |
| Height (in) | 4.9 | 4.9 | 8.75 |
| Depth (in) | 10.4 | 12.4 | 12.75 |
| Weight (lbs) | 4.08 | 5.5 | 6 |
| Performance | Identical | Identical | Identical |
| Biocompatibility | FDA cleared<br>electrodes | FDA cleared<br>electrodes | FDA cleared<br>electrodes |
| Mechanical safety | Identical | Identical | Identical |
| Anatomical Sites | Identical | Identical | Identical |
| Number of<br>channels | 4 | 4 | 2/4 |
| Russian | No | Yes | Yes |
| Burst Modulated<br>Alternating<br>Current (Aussie) | Yes | Yes | Yes |
| Interferential | No | Yes | Yes |
| Microcurrent | No | Yes | Yes |
| TENS | No | Yes | Yes |
| Premodulated | No | Yes | Yes |
| Voltage Input | 100/240V<br>50/60Hz<br>Bivolt | 100/240V<br>50/60Hz<br>Bivolt | 100/240V<br>50/60Hz<br>1.0A |
| Output | +24V<br>7.3A+24V<br>7.3A | +24V<br>7.3A+24V<br>7.3A | +24V<br>7.3A+24V<br>7.3A |
| Electrical Class | II | II | II |
| Electrical Type | BF Type | BF Type | BF Type |
| Method of line<br>current isolation | Double Isolation | Double Isolation | Fuse-Two 5.6A<br>Time Lag |
| Patient leakage<br>control-normal<br>condition | 0.0508mA | 0.0508mA | 69μA |
| Patient leakage<br>control-single fault<br>condition | 0.0252mA | 0.0252mA | 31μA |

The above comparison chart shows that all four devices are identical in every aspect regarding intended use, indications for use, contraindications, target population and human factors

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|--|---|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|----------------------------------|---|
|--|---|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|----------------------------------|---|

| Software<br>Microprocessor | Yes | Yes | Yes |
|---------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------------|
| Automatic<br>overload trip | Yes | Yes | Yes |
| Automatic shut off | Yes | Yes | Yes |
| Temperature<br>range during<br>transport and<br>storage | 41°F-122°F | 41°F-122°F | 59°F-104°F |
| Environment<br>operating<br>temperature<br>range | 41°F-113°F | 41°F-113°F | 59°F-104°F |
| Locking feature | Keyboard lock<br>safety feature | Keyboard lock<br>safety feature | Keyboard lock<br>safety feature |
| Treatment timer | Treatment timer<br>with auto shut off | Treatment timer<br>with auto shut off | Treatment timer<br>with auto shut off |
| Auto test and<br>repeat | Automatic setting<br>and repeat<br>treatment | Automatic setting<br>and repeat<br>treatment | Automatic setting<br>and repeat<br>treatment |
| Safety standards<br>requirements | ISO 13485<br>IEC 60601-1<br>IEC 60601-2<br>IEC 60602-10<br>CE | ISO 13485<br>IEC 60601-1<br>IEC 60601-2<br>IEC 60602-10<br>CE | ISO 13485<br>IEC 60601-1<br>IEC 60601-2<br>IEC 60602-10<br>UL 60602 |
| Electromagnetic<br>compatibility | IEC 60601-1-<br>2001/A:2004 | IEC 60601-1-<br>2001/A:2004 | IEC 60601-1-<br>2001/A:2004 |

The preceding comparison chart shows that all three devices are similar in every aspect. We assessed the indications for use, intended use, technological characteristics, voltages, inputs, outputs, sizes, weight, types of materials, patient cable construction, software construction, user interface, control parameters, level of concern (software), waveforms, treatment times and the results of each treatment.

We have concluded that the Neurodyn and the Neurodyn Aussie are as safe and effective as the Vectra Genisys. The Ibramed devices deliver the same currents for the same intended uses as the Vectra Genisys. Thus, we found them to be substantially equivalent.

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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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the symbol. The text is in all caps and is oriented to follow the curve of the circle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

### December 19, 2012

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Ibramed Equipamentos Medicos % Ms. Lilian Llull Ibramed U.S. Agent TechLink International 18851 NE 29th Avenue 720 Aventura. FL 33180

K121369 Re:

> Trade/Device Name: Neurodyn/Neurodyn Aussie Powered Muscle Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ, IPF, LIH, GZI Dated: November 29, 2012 Received: December 5, 2012

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.

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## Page 2 - Ms. Lillian Llull

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use Statement

Neurodyn Series: Neurodyn/ Neurodyn Aussie

### 510(k) Number: K121369

#### As a TENS device:

- Symptomatic relief of chronic (long term) intractable pain l
- 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 traumatic surqical 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 ー
- Prevention or retardation of disuse atrophy in post-injury type conditions ।
- Increase local blood circulation .
- Muscle re-education l
- 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

Prescription Use ____________ (Part 21 CFR 801 Subpart D) AND/OR

#### Over-The-Counter Use __________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED

Concurrence of CDRH, Office of Device Evaluation
(ODE) Page 1 of 1

Division of Neurological and I Medicine Devices 510(k) Number