NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS

K131923 · Techlink International · GZI · Jul 3, 2014 · Neurology

Device Facts

• Record ID: K131923
• Device Name: NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS
• Applicant: Techlink International
• Product Code: GZI · Neurology
• Decision Date: Jul 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indications for 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. Indications for TENS device: - Symptomatic relief of chronic (long term) intractable pain - Symptomatic relief of post-traumatic acute pain and post surgical pain

Device Story

Neurodyn Portable TENS and TENS/FES are two-channel electrical stimulators used for TENS and FES therapies. The device features an ABS cabinet, LCD display, and mechanical keyboard. It operates via AC/DC power. A licensed health professional prescribes and supervises use. The device delivers electrical pulses to muscles or nerves to provide pain relief or improve gait in partially paralyzed patients. The clinician adjusts stimulation parameters via the interface. The device includes a treatment timer with auto-shutoff and a keyboard lock for safety. It is intended for clinical use to manage pain or assist in physical rehabilitation.

Clinical Evidence

Bench testing only. The device underwent electrical safety and performance testing in compliance with IEC 60601-1, IEC 60601-2, and IEC 60602-10 standards. No clinical data was required or provided.

Technological Characteristics

ABS plastic enclosure; LCD display; two-channel output; 100mA peak-to-peak current; AC/9V DC power; Type BF electrical protection; Class II device. Operates via TENS and FES waveforms. Manual control interface with keyboard lock and treatment timer.

Indications for Use

Indicated for partially paralyzed patients requiring leg/ankle muscle stimulation to improve gait (FES) and patients requiring symptomatic relief of chronic intractable pain, post-traumatic acute pain, or post-surgical pain (TENS).

Regulatory Classification

Identification

An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.

Predicate Devices

• Neurodyn/Aussie Powered Muscle Stimulator by Ibramed (K121369)
• 300 PV Complete Electrotherapy System by EMPI (K021100)

Submission Summary (Full Text)

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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 bold, sans-serif font. The symbol is composed of thick, horizontal lines connected by vertical elements, creating a geometric design. The overall impression is modern and corporate.

# JUL 0 3 2014

## 510(k) Summary

510 (k) Number: K131923 Date of Submission: July 1, 2014

#### Submitter:

IBRAMED EQUIPAMENTOS MEDICOS Avenida Dr. Carlos Burgos 2800 Amparo - Sao Paulo - Brasil

TEL - 5519-3817-9633 FAX - 5519-7816-7980

#### Official Contact:

Tara Conrad TechLink International Consulting PO Box 694125 Miami, FL 33269

TEL - [phone]

Common Name: Trade Name:

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Classification: Product Code: Classification Panel: Regulation Numbers: Substantial Equivalence: External Functional Neuromusclar Stimulator Neurodyn Portable TENS; Neurodyn Portable TENS/FES

Class II GZJ; GZI Neurology 21 CFR 882.5890 and 21 CFR 882.5810 K121369 Neurodyn/Aussie Powered Muscle Stimulator by Ibramed; K021100 300 PV. Complete Electrotherapy System by EMPI

#### Indications for Use

Indications for 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.

Indications for TENS device:

- Symptomatic relief of chronic (long term) intractable pain
- Symptomatic relief of post-traumatic acute pain and post surgical pain

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Image /page/1/Picture/0 description: The image shows a logo for IBRAMED. The logo consists of a stylized "I" shape above the word "IBRAMED" in a bold, sans-serif font. Below the word "IBRAMED" is the phrase "Device Description" in a smaller, sans-serif font. The logo is black and white.

### Neurodyn Poratble TENS/FES

The device NEURODYN PORTABLE TENS/FES is a two output channel stimulator, operated in power supply 100 to 240 V 50-60 Hz AC/9V DC converter, with independent controls, Liquid Crystal Display. with 4 ½ digits, mechanical contact keyboard and ABS cabinet.

Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation) FES (Functional Electrical Stimulation)

The equipment must be used only under the prescription and supervision of a licensed health professional.

Neurodyn Portable Tens/Fes

Characteristics:

TENS: two 100mA peak to peak channels FES: two 100mA peak to peak channels Input Power: 15VA Temperature Range During Transport and Storage: 41 to 122°F Environment Operating Temperature Range: 41 to 113°F Electrical Class: Class II Electrical Protection: Type BF

#### Neurodyn Portable TENS

The device NEURODYN PORTABLE TENS is a two output channel stimulator, operated in power supply 100 to 240 V 50-60 Hz AC/9V DC, with independent controls, Liquid Crystal Display with 4 ½ digits, mechanical contact keyboard and ABS cabinet.

Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation)

The equipment must be used only under the prescription and supervision of a licensed health professional.

#### Neurodyn Portable Tens

Characteristics:

TENS: two 100mA peak to peak channels

Input Power: 15VA

Temperature Range During Transport and Storage: 41 to 122°F Environment Operating Temperature Range: 41 to 113°F Electrical Class: Class II

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Image /page/2/Picture/0 description: The image shows the logo for IBRAMED, which is a black, stylized "I" with three horizontal lines above the word "IBRAMED". Below the logo, the text "Electrical Protection: Type BF" is written in a smaller font. The logo and text are all in black and are set against a white background.

## Device Comparison Table

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| Device name | Neurodyn | Neurodyn | Neurodyn | 300 PV Empi |
|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Portable | Portable TENS | | |
| | TENS/FES | | | |
| K Number | K131923 | K131923 | K121369 | K021100 |
| Manufacturer<br>Indications for Use | Ibramed<br>As a FES device:<br>Stimulation of the<br>muscles in the leg<br>and ankle of<br>partially<br>paralyzed<br>patients to<br>provide flexion of<br>the foot and thus<br>improve the<br>patient's gait. | Ibramed | Ibramed | Empi<br>As a FES device:<br>Stimulation of<br>muscles in the leg<br>and ankle of<br>partially paralyzed<br>patients to provide<br>flexion of the foot<br>and thus improve<br>the patient's gait.<br>As a NMES device:<br>Retarding or<br>preventing disuse<br>atrophy<br>Maintaining or<br>increasing range<br>of motion<br>Reeducating<br>muscles<br>Relaxation of<br>muscle spasm<br>Increasing local<br>blood circulation<br>Prevention of<br>venous thrombosis<br>of the calf muscles |
| | As a TENS<br>device:<br>Symptomatic<br>relief of chronic<br>(long term)<br>intractable pain<br>Symptomatic<br>relief of post-<br>traumatic acute<br>pain and post<br>surgical pain | As a TENS<br>device:<br>Symptomatic<br>relief of chronic<br>(long term)<br>intractable pain<br>Symptomatic<br>relief of post-<br>traumatic acute<br>pain and post<br>surgical pain | As a TENS<br>device:<br>Symptomatic<br>relief of chronic<br>(long term)<br>intractable pain<br>Symptomatic<br>relief of post-<br>traumatic acute<br>pain and post<br>surgical pain | immediately after<br>surgery<br>As a TENS device:<br>Symptomatic relief<br>of chronic (long<br>term) intractable<br>pain<br>Symptomatic relief<br>of post-traumatic<br>acute pain and<br>post surgical pain |
| | | | AS an<br>Interferential and<br>Premodulated<br>device:<br>Symptomatic<br>relief of chronic<br>pain, acute post<br>traumatic pain,<br>or acute post<br>traumatic<br>surgical pain | As an<br>Interferential This<br>device is not been<br>used as a<br>predicate for the<br>Interferential<br>waveform |
| | | | | |
| | | | As a Burst<br>Modulated<br>Alternating<br>Current -Russian<br>device:<br>Temporary<br>relaxation of<br>muscle spasms<br>Prevention or<br>retardation of<br>disuse atrophy in<br>post-injury type<br>conditions<br>Increase local<br>blood circulation<br>Muscle re-<br>education<br>Maintaining or<br>increasing range<br>of motion | |
| | | | As a Burst<br>Modulated<br>Alternating<br>Current (Aussie)<br>device:<br><br>Temporary<br>relaxation of<br>muscle spasms<br><br>Prevention or<br>retardation of<br>disuse atrophy in<br>post-injury type<br>conditions<br><br>Increase local<br>blood circulation<br><br>Muscle re-<br>education | |
| | | | As a Microcurrent<br>device:<br>Symptomatic<br>relief of chronic<br>intractable pain<br><br>Symptomatic<br>relief of post-<br>traumatic acute<br>pain and post<br>surgical pain | |
| Technological<br>characteristics<br>Medium-frequency<br>alternating current<br>(MFAC) | Identical | Identical | Identical | Identical |
| Device Material | ABS plastic panel<br>LCD display | ABS plastic panel<br>LCD display | ABS plastic panel<br>LCD display | ABS plastic panel<br>LCD display |
| Width (in) | 3.07 | 3.07 | 6.8 | 9.75 |
| Height | 1.97 | 1.97 | 4.9 | 8.75 |

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Image /page/4/Picture/0 description: The image shows a logo for IBRAMED. The logo is black and white and features a stylized "I" shape above the word "IBRAMED" in bold, capital letters. Below the word "IBRAMED" is a horizontal line, and below that is the number 5.83.

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| Depth | 5.83 | 5.83 | 12.4 | 12.75 |
|----------------------|--------------------|--------------------|---------------------|-------------------|
| Number of | 2 | 2 | 4 | র্ব |
| Channels | | | | |
| Temperature | -58°f-122°f | -58°f-122°f | 45°f-110°f | -40 to 158°F |
| range during | | | | |
| transport and | | | | |
| storage | | | | |
| Environment | 23°F-113°F | 23°F-113°F | 45°F-110°F | 50 to 104°F |
| operating | | | | |
| temperature range | | | | |
| Method of current | Double Isolation | Double Isolation | Double Isolation | Double Isolation |
| isolation | | | | |
| Patient leakage | 0.0497 mA | 0.0497 mA | 0.0508mA | 0.0502mA |
| control-normal | | | | |
| condition | | | | |
| Patient leakage | 0.0245 mA | 0.0245 mA | 0.0252mA | 0.0248mA |
| control-single fault | | | | |
| condition | | | | |
| Software | Yes | Yes | Yes | Yes |
| Microprocessor | | | | |
| Automatic | No | No | No | No |
| overload trip | | | | |
| Automatic shut off | No | No | No | No |
| Locking feature | Keyboard lock | Keyboard lock | Keyboard lock | Keyboard lock |
| | safety feature | safety feature | safety feature | safety feature |
| Treatment timer | Treatment timer | Treatment timer | Treatment timer | Treatment timer |
| | with auto shut off | with auto shut off | with auto shut off | |
| Safety standards | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 |
| requirements | IEC 60601-2 | IEC 60601-2 | IEC 60601-2 | IEC 60601-2 |
| biocompatibility | IEC 60602-10 | IEC 60602-10 | IEC 60602-10 | IEC 60602-10 |
| Chemical | Has no Chemical | Has no Chemical | Has no Chemical | Has no Chemical |
| Composition | Composition | Composition | Composition | Composition |
| Energy Source | AC/9.0 DC | AC/9.0 DC | a.0 DC | 3.0 DC |
| Electrical Output | TENS 0 to 100mA | TENS 0 to 100mA | FES 0 to 120mA | NMES 0 to 100mA |
| Parameters | peak to peak | peak to peak | peak to peak | peak to peak |
| | FES 0 to 100mA | | RUSSIA 0 to | TENS 0 to 50mA |
| | peak to peak | | 120mA peak to | peak to peak |
| | | t | peak | HV 0 to 300V peak |
| | | | Interferential 0 to | |
| | | | 120mA peak to | |
| | | | peak | |
| | | | Aussie 0 to | |
| | | | 120mA peak to | |
| | | | peak | |
| | | | Micro current 0 to | |
| Modes of | TENS | TENS | 990pA peak<br>TENS | TENS |
| stimulation | FES | | FES | NMES |
| | | | INTERFERENTIAL | INTERFERENTIAL |
| | | | RUSSA | HV |
| | | | AUSSIE | |
| | | | DIRECT CURRENT | |
| | | | MICRO CURRENT | |
| Frequency Hz | 0.5 to 250 | 0.5 to 250 | 0.5 to 250 | 0.5 to 150 |
| Phase Duration us | 50 to 500 | 50 to 500 | 50 to 500 | 50 to 400 |
| Current Output | 104 | 104 | 125 | 200 |
| mA | | | | |
| Total Charge per | 52 | 52 | 57 | 40 |
| pulse (two | | | | |
| phases). | | | | / |
| Maximum Average | 0.024 | 0.027 | 0.040 | 0.0088 |
| Power Density | | | | |
| | | | | |

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Image /page/5/Picture/0 description: The image shows a logo for IBRAMED. The logo is black and white and features a stylized letter "I" above the word "IBRAMED". Below the word "IBRAMED" is the text "W/cm^2".

### Substantial Equivalence

The subject and the predicate devices have the same intended use, the same operating principle, and are similar in their hardware configuration.

## Technology

The Neurodyn Portable devices are External Functional Neuromusclar Stimulator machines that operate using the tens and/or fes waveforms.

#### Conclusion

The Neurodyn Portable TENS and Neurodyn Portable TENS/FES machines are substantially equivalent to the currently legally marketed Neurodyn and 300 PV. The non-clinical testing demonstrates that the subject devices are as safe, as effective and perform as well or better than the legally marketed predicated devices. The IEC testing showed that the subject devices comply with Medical Electrical Device requirements for external functional neuromusclar stimulator. The subject devices passed all aspects of the clinical tests. This shows compliance with the standards currently in place for such medical devices. Compliance includes but is not limited to electrical safety (power input, electrical classification, limitation of voltage/energy, etc.).

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 3, 2014

Ibramed Equipamentos Medicos C/O TechLink International Consulting Attn: Tara Conrad 18851 NE 29th Avenue Suite 720 Aventura, FL 33180

Re: K131923

Trade Name: Neurodyn Portable TENS/FES and Neurodyn Portable TENS Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: Class II Product Code: GZI, GZJ Dated: June 23, 2014 Received: June 25, 2014

Dear Ms. Conrad:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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

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Page 2 of 2 - Ms. Tara Conrad

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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resources/or You/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/ReportalProblem/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 hup://www.fdagov/MedicalDevices/Resourcesfor You/Industry/default.hum.

Sincerely vours.

Felipe Aquel -S

for

Carlos L. Peña. PhD, MS 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):_____________________________________________________________________________________________________________________________________________________

Neurodyn Portable TENS and Neurodyn Portable TENS/FES Device Name:_

Indications For Use:

Indications for 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.

Indications for TENS device:

- Symptomatic relief of chronic (long term) intractable pain
- Symptomatic relief of post-traumatic acute pain and post surgical 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 NEEDED).

Concurrence of CDRH, Office of Device Evaluation (ODE)

Felipe Aguel Date: 2014.07.03 17:01:44 -04'00' -2

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