NEURODYN COMPACT, NEURODYN II
Device Facts
| Record ID | K131917 |
|---|---|
| Device Name | NEURODYN COMPACT, NEURODYN II |
| Applicant | Ibramed Equipamentos Medicos |
| Product Code | IPF · Physical Medicine |
| Decision Date | Apr 29, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5850 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
Indications for FES waveform: - Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the patient's gait. Indications for TENS waveform: - Symptomatic relief of chronic (long term) intractable pain - Symptomatic relief of post-traumatic acute pain and post surgical pain Indications for Russian waveform: - Temporary relaxation of muscle spasms - Prevention or retardation of disuse atrophy in post-injury type conditions - Increase local blood circulation - Muscle re-education - Maintaining or increasing range of motion
Device Story
Neurodyn II (4-channel) and Neurodyn Compact (2-channel) are powered muscle stimulators for clinical use. Devices deliver TENS, FES, and Russian (burst modulated medium frequency) waveforms to patients via electrodes. Operation involves user-selected parameters via mechanical keyboard and backlit graphic display. Output is controlled by microprocessor-based circuitry. Healthcare providers use these devices to manage pain, improve gait in paralyzed patients, and support physical therapy goals like muscle re-education and atrophy prevention. Benefits include non-invasive pain relief and functional muscle stimulation. Devices are housed in ABS cabinets with acrylic covers and operate on 100-240V power.
Clinical Evidence
Bench testing only. Compliance with IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-1-4 (programmable systems), and IEC 60601-2-10 (nerve/muscle stimulators) demonstrated. No clinical trial data provided.
Technological Characteristics
Powered muscle stimulator; 2 or 4 output channels; ABS plastic cabinet; backlit LCD; microprocessor-controlled. Waveforms: TENS, FES, Russian (burst modulated medium frequency). Electrical output: 0-120mA peak-to-peak. Power: 100-240V, 50/60Hz. Double isolation. Safety standards: IEC 60601-1, 60601-1-2, 60601-1-4, 60601-2-10.
Indications for Use
Indicated for partially paralyzed patients (leg/ankle muscle stimulation for gait flexion); patients with chronic intractable pain, post-traumatic acute pain, or post-surgical pain; and patients requiring muscle spasm relaxation, atrophy prevention, circulation improvement, muscle re-education, or range of motion maintenance.
Regulatory Classification
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.
Predicate Devices
- Neurodyn/Aussie Powered Muscle Stimulator by Ibramed (K121369)
- 300 PV Complete Electrotherapy System by EMPI (K021100)
Related Devices
- K210572 — Neurodyn V2.0, Neurodyn Aussie V2.0 · Ibramed Equipamentos Medicos · May 11, 2021
- K131923 — NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS · Techlink International · Jul 3, 2014
- K131629 — NEURODYN MULTIWAVE, AUSSIE SPORT · Ibramed Equipamentos Medicos · Nov 26, 2013
- K121369 — NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR · Ibramed Equipamentos Medicos · Dec 19, 2012
- K021100 — 300 PV COMPLETE ELECTROTHERAPY SYSTEM · Empi · Jun 18, 2002
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for IBRAMED. The logo consists of the word "IBRAMED" in bold, sans-serif font, with a stylized symbol above it. The symbol is composed of three horizontal lines on the top and bottom, connected by a vertical line in the center, creating a symmetrical design. The logo is black and white.
510 (k) Number: K131917
Date of Submission: April 29, 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 18851 NE 29th Avenue Suite 720 Aventura, FL 33180
TEL - (305) 377-0077
| Common Name: | Powered Muscle Stimulator |
|--------------------------|----------------------------------------|
| Trade Name: | Neurodyn Compact; Neurodyn II |
| Classification: | Class II |
| Product Code: | GZJ; GZI; IPF |
| Classification Panel: | Neurology |
| Regulation Numbers: | 21 CFR 890.5850 |
| Substantial Equivalence: | K121369 Neurodyn/Aussie Powered Muscle |
| | Stimulator by Ibramed; K021100 300 PV |
| | Complete Electrotherapy System by EMPI |
#### Indications for Use
Indications for FES waveform:
- Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait.
Indications for TENS waveform:
- Symptomatic relief of chronic (long term) intractable pain
- Symptomatic relief of post-traumatic acute pain and post surgical pain
Indications for Russian waveform:
- Temporary relaxation of muscle spasms
- Prevention or retardation of disuse atrophy in post-injury type conditions
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Image /page/1/Picture/0 description: The image shows the word "IBRAMED" in bold, black, capital letters. Above the word is a black graphic design that features three horizontal lines on the top and bottom, with a vertical line connecting them in the middle. The design is symmetrical and bold. The overall image has a clean and professional look.
- Increase local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
#### Device Description
The device NEURODYN II is a four output channel stimulator, operated in power supply 100 to 240 V, 50-60 Hz, with independent controls, graphic display backlit blue, mechanical contact keyboard and ABS cabinet with acrylic cover.
Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation) FES (Functional Electrical Stimulation) RUSSIAN CURRENT (Burst Modulated Medium Frequency)
Characteristics:
TENS: four 120mA peak to peak channels FES: four 120mA peak to peak channels RUSSIAN: four 120mA peak to peak channels Electrical Feed: 100 a 240V (50/60Hz) Input Power: 85VA Temperature Range During Transport and Storage: 41 to 122°F Environment Operating Temperature Range: 41 to 113°F
The device NEURODYN COMPACT is a two output channel stimulator. operated in power supply 100 to 240 V, 50-60 Hz, with independent controls, graphic display backlit blue, mechanical contact keyboard and ABS cabinet with acrylic cover.
Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation) FES (Functional Electrical Stimulation) RUSSIAN CURRENT (Burst Modulated Medium Frequency)
Characteristics:
TENS: four 120mA peak to peak channels FES: four 120mA peak to peak channels RUSSIAN: four 120mA peak to peak channels Electrical Feed: 100 a 240V (50/60Hz) Input Power: 85VA Temperature Range During Transport and Storage: 41 to 122°F Environment Operating Temperature Range: 41 to 113°F
#### Device Comparison Table
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Image /page/2/Picture/0 description: The image shows a logo for IBRAMED. The logo is black and white and features the word "IBRAMED" in a bold, sans-serif font. Above the word is a stylized symbol that resembles a stylized letter "I" with horizontal lines extending from the top and bottom. There is also the text "BR" and "AMC 31".
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# 510(k) Summary
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| Device name | Neurodyn<br>Compact | Neurodyn II | Neurodyn | 300 PV Empi |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | Pending | Pending | K121369 | K021100 |
| Manufacturer | Ibramed | Ibramed | Ibramed | Empi |
| Indications for Use | As a FES device:<br>Stimulation of the<br>muscles in the<br>leg and<br>ankle of partially<br>paralyzed<br>patients to<br>provide flexion<br>of the foot and<br>thus improve the<br>patient's gait. | As a FES device:<br>Stimulation of the<br>muscles in the<br>leg 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. | | 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<br>immediately after<br>surgery |
| | 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 | 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 a Burst<br>Modulated<br>Alternating | As a Burst<br>Modulated<br>Alternating | 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<br>As a Burst<br>Modulated<br>Alternating | As an<br>Interferential This<br>device is not been<br>used as a<br>predicate for the<br>Interferential<br>waveform |
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Image /page/3/Picture/0 description: The image shows the word "IBRAMED" in bold, black, capital letters. Above the word is a symbol that looks like a stylized "I" or a geometric shape. The symbol is also in black and is composed of horizontal lines and a trapezoidal shape in the middle.
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# 510(k) Summary
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| | | | 510(k) Summary | | | | |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|--|-----------|--|
| | Russian device: | device: | device: | | | | |
| | 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-education<br>Maintaining or<br>increasing range<br>of motion | 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-education<br>Maintaining or<br>increasing range<br>of motion | 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-education<br>Maintaining or<br>increasing range<br>of motion<br><br>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-education<br><br>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 | alternating current<br>(MFAC) | 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 | | | |
| Width (in) | 6.89 | 6.89 | 14.6 | 9.75 | | | |
| Height | 4.53 | 4.53 | 4.9 | 8.75 | | | |
| Depth | 10.83 | 10.83 | 12.4 | 12.75 | | | |
| Number of Channels | 2 | 4 | 4 | 4 | | | |
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Image /page/4/Picture/0 description: The image shows the logo for IBRAMED. The logo consists of the word "IBRAMED" in bold, block letters. Above the word is a stylized graphic that resembles a capital "I" with horizontal lines extending from either side of the top and middle portions of the "I" shape.
| Temperature range<br>during transport<br>and storage | 59°f-104°f | 59°f-104°f | 41°f-122°f | -40 to 158°F |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Environment<br>operating<br>temperature range | 41°f-113°f | 41°f-113°f | 41°F-113°F | 50 to 104°F |
| Performance | Identical | Identical | Identical | Identical |
| Biocompatibility | FDA cleared<br>electrodes | FDA cleared<br>electrodes | FDA cleared<br>electrodes | FDA cleared<br>electrodes |
| Mechanical safety | Identical | Identical | Identical | Identical |
| Anatomical Sites | Identical | Identical | Identical | Identical |
| Burst Modulated<br>Alternating Current<br>(Russian) | Yes | Yes | Yes | No |
| Burst Modulated<br>Alternating Current<br>(Aussie) | No | No | Yes | No |
| Interferential | No | No | Yes | Yes |
| Microcurrent | No | No | Yes | No |
| TENS | Yes | Yes | Yes | Yes |
| FES | Yes | Yes | No | Yes |
| Premodulated | No | No | Yes | Yes |
| Method of current<br>isolation | Double Isolation | Double Isolation | Double Isolation | Double Isolation |
| Patient leakage<br>control-normal<br>condition | 0.0347 mA | 0.0347 mA | 0.0508mA | 0.0502mA |
| Patient leakage<br>control-single fault<br>condition | 0.0162 mA | 0.0162 mA | 0.0252mA | 0.0248mA |
| Software<br>Microprocessor | Yes | Yes | Yes | Yes |
| Automatic overload<br>trip | No | No | No | No |
| Automatic shut off<br>Locking feature | No | No | No | No |
| | Keyboard lock<br>safety feature | Keyboard lock<br>safety feature | Keyboard lock<br>safety feature | Keyboard lock<br>safety feature |
| Treatment timer | Treatment timer<br>with auto shut<br>off | Treatment timer<br>with auto shut<br>off | Treatment timer<br>with auto shut off | Treatment timer |
| Safety standards<br>requirements<br>biocompatibility | IEC 60601-1<br>IEC 60601-2<br>IEC 60602-10<br>IEC 60101-1-4 | IEC 60601-1<br>IEC 60601-2<br>IEC 60602-10<br>IEC 60101-1-4 | IEC 60601-1<br>IEC 60601-2<br>IEC 60602-10 | IEC 60601-1<br>IEC 60601-2<br>IEC 60602-10 |
| Chemical<br>Composition | Has no Chemical<br>Composition | Has no Chemical<br>Composition | Has no Chemical<br>Composition | Has no Chemical<br>Composition |
| Energy Source | 100 to 240 Volts<br>50/60Hz | 100 to 240 Volts<br>50/60Hz | 100 to 240 Volts<br>50/60Hz | 3.0 DC |
| Electrical Output<br>Parameters | TENS 0 to<br>120mA peak to<br>peak<br>FES 0 to 120mA<br>peak to peak<br>RUSSIA 0 to<br>120mA peak to<br>peak | TENS 0 to<br>120mA peak to<br>peak<br>FES 0 to 120mA<br>peak to peak<br>RUSSIA 0 to<br>120mA peak to<br>peak | FES 0 to 120mA<br>peak to peak<br>RUSSIA 0 to<br>120mA peak to<br>peak<br>Interferential 0 to<br>120mA peak to<br>peak<br>Aussie 0 to<br>120mA peak to<br>peak<br>Micro current 0 to<br>990µA peak | NMES 0 to 100mA<br>peak to peak<br>TENS 0 to 50mA<br>peak to peak<br>HV 0 to 300V<br>peak |
| Frequency | 0.5-250 Hz | 0.5-250 Hz | 0.5-250 Hz | 0.5-150 Hz |
| | Phase Duration | Phase Duration | Phase Duration | Phase Duration |
| Phase Duration | 50-500μs | 50-500μs | 50-500μs | 50-400 μs |
| Current Output | 124 mA @500Ω | 124 mA @500Ω | 125 mA @500Ω | 200 mA @ 500Ω |
| | 110mA @2KΩ | 110mA @2KΩ | 95mA @2KΩ | 115 mA @ 2KΩ |
| | 39.2mA @10KΩ | 39.2mA @10KΩ | 23mA @10KΩ | 25 mA @ 10KΩ |
| Charge per Phase | 58μC | 58μC | 56μC | 40@ 500Ω |
| Max. avg. power density | 0.038W/cm2 | 0.038W/cm2 | 0.037W/cm² | 0.0088W/cm² |
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Image /page/5/Picture/0 description: The image shows a logo for IBRAMED. The logo consists of the word "IBRAMED" in large, bold, black letters. Above the word is a symbol that looks like a stylized "I" or a geometric shape. The symbol is also in black and is composed of thick lines and rectangular shapes.
## 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 II and Neurodyn Compact devices are powered muscle stimulator machines that operate using the TENS, Russian and FES waveforms.
#### Non-Clinical Testing
This submission includes testing results of the Neurodyn II and Neurodyn Compact.
The devices have been tested according to:
- IEC 60601-1 .
- IEC 60601-1-2 ●
- IEC 60601-1-4 .
- . IEC 60601-2-10
IEC 60601-1: The general standard IEC 60601-1 - Medical equipment/medical electrical equipment - Part 1: General requirements for basic safety and essential performance - gives general requirements of the series of standards. It is used as a bench mark for many electrical medical devices. Both the subject and predicate devices comply with this standard.
The standard contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone.
IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
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Image /page/6/Picture/0 description: The image shows a logo for IBRAMED. The logo consists of the word "IBRAMED" in a bold, sans-serif font, with a stylized symbol above it. The symbol is composed of three horizontal bars connected by a vertical bar in the center, with angled lines extending from the top bar to the sides.
This collateral standard applies to electromagnetic compatibility of medical electrical equipment and medical electrical systems. The object of this collateral standard is to specify general requirements and tests for electromagnetic compatibility of medical electrical equipment and medical electrical systems. They are in addition to the requirements of the general standard and serve as the basis for particular standards. Both the subject and predicate devices comply with this standard.
IEC 60601-2-10: Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
IEC 60601-2-10:2012 specifies the requirements for the safety and essential performance of nerve and muscle stimulators, for use in the practice of physical medicine. This includes transcutaneous electrical nerve stimulators (TENS) and electrical muscle stimulators (EMS). This second edition cancels and replaces the first edition, published in 1987 and its Amendment 1 (2001). This edition constitutes a technical revision and is aligned with IEC 60601-1:2005+A1:2012.
IEC 60601-1-4: Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
Specifies requirements for the process by which a programmable electrical medical system is designed. Serves as the basis of requirements of Particular Standards, including serving as a quide to safety requirements for the purpose of reducing and managing risk. This standard covers requirement specification, architecture, detailed design and implementation software development, modification, verification and validation, marking and accompanying documents.
#### Conclusion
The Neurodyn Compact and Neurodyn II machines are substantially equivalent to the currently legally marketed Neurodyn and 300 PV. The nonclinical 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 powered muscle stimulators. 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
April 29, 2014
Ibramed Equipamentos Medicos c/o Ms. Tara Conrad TechLink International Consulting 18851 NE 29th Avenue Suite 720 Aventura. FL 33180
Re: K131917
Trade Name: Neurodyn Compact and Neurodyn II Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF, GZJ, GZI Dated: April 14, 2014 Received: April 18, 2014
Dear Ms. Conrad:
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 reclassilied 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 (sec above) into cither 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 or any with all the Act s requirements, including, but not limited to: registration and listing (21
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Page 2 of 2 - Ms. Tara Conrad
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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor 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/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,
# Felipe Aquel -S
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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
#### Indications for Use
510(k) Number (if known) K131917
Device Name
Neurodyn Compact and Neurodyn II
Indications for Use (Describe)
Indications for FES waveform:
- Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the patient's gait.
Indications for TENS waveform:
- Symptomatic relief of chronic (long term) intractable pain
- Symptomatic relief of post-traumatic acute pain and post surgical pain
Indications for Russian waveform:
- Temporary relaxation of muscle spasms
- Prevention or retardation of disuse atrophy in post-injury type conditions
- Increase local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
Type of Use (Select one or both, as applicable)
[x] Prescription Use (Part 21 CFR 801 Subpart D)
[] Over-The-Counter Use (21 CFR 801 Subpart C)
# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
..
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
# 9 -04'00'
FORM FDA 3881 (1/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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