Neurodyn V2.0, Neurodyn Aussie V2.0

{0}------------------------------------------------ May 11, 2021 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that. Ibramed Equipamentos Medicos % Rodrigo Abreu Regulatory Specialist United Regulatory LLC 12343 NW 25th St Coral Springs, Florida 33065 Re: K210572 Trade/Device Name: Neurodyn V2.0, Neurodyn Aussie V2.0 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF Dated: February 26, 2021 Received: February 26, 2021 Dear Rodrigo Abreu: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Patrick Antkowiak, PhD Assistant Director (Acting) DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use #### 510(k) Number (if known) K210572 Device Name Neurodyn V2.0, Neurodyn Aussie V2.0 #### Indications for Use (Describe) Neurodyn V2.0 Stimulators are intended for: 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 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 As a DC/Polarized device: -Relaxation of Muscle Spasm As a High Voltage Pulsed current device: - Muscle re-education - Relaxation of Muscle Spasms - Maintaining or increasing range of motion - Increasing local blood circulation - Prevention or retardation of disuse atrophy Neurodyn Aussie V2.0 Stimulators are intended for: 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 {3}------------------------------------------------ - 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 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for IBRAMED. The logo consists of a stylized symbol above the word "IBRAMED". The symbol is made up of four blue curved shapes, two on top and two on the bottom, with a black hourglass shape in the center. The word "IBRAMED" is written in a bold, sans-serif font. Ibramed Fouinamentos Médicos Av. Dr. Carlos Burgos, 2800 - Jardim Itália, SP, 13901-080 Brazil 3817 9633 510(k) SUMMARY May 10, 2021 - A) Submitter's Name: Ibramed Equipamentos Médicos Owner / Operator Registration Number: 3010362721 Manufacture Registration Number: 3010362721 - B) Address: Av. Dr. Carlos Burgos, 2800 Jardim Itália, Amparo SP, 13901-080 Brazil - C) Phone and Fax Numbers Phone: + 55 19 3817 9633 - D) Contact Person: Fábio Alexandre Pinto Tel.: +55 19 3817-9636 - E) Preparation Date: May 10, 2021 - F) Classification Name: Powered Muscle Stimulator Common / Usual Name: Powered Muscle Stimulator Proprietary Name: Neurodyn V2.0; Neurodyn Aussie V2.0 Product Code: IPF Class: Class II Regulation: 21 CFR 890.5850 #### G) Device Description NEURODYN v2.0 is a transcutaneous neuromuscular stimulator of four channels with independent controls for treatments with: AUSSIE CURRENT (with Medium Frequency Current modulated in Burst), RUSSIAN CURRENT (Medium Frequency Current modulated in Burst), FES CURRENT (Functional Electrical Stimulation),TENS CURRENT(Transcutaneous Electrical Nerve Stimulation), INTERFERENTIAL CURRENT (IFC-T), PREMODULATED INTERFERENTIAL CURRENT (IFC-B) BIPOLAR (Medium Frequency Current modulated in Amplitude), and with two independent control channels for the treatments with: MICROCURRENT (Microcurrent Electrical Neuromuscular Stimulation), DIRECT CURRENT /POLARIZED CURRENT and HIGH VOLTAGE PULSED CURRENT (High Volt Pulsed Current). NEURODYN AUSSIE V2.0 transcutaneous neuromuscular stimulator is a four-channel stimulator with independent controls for current therapy used in AUSSIE CURRENT (Burst Modulated Medium Frequency). #### H) Substantial Equivalence: The Neurodyn V2.0 is equivalent with the following products: | Predicate<br>type | 510(k)<br>Number | Model | Company | |------------------------|------------------|-------------------------------------------|------------------------------| | Predicate | K131629 | Neurodyn Multiwave; Neurodyn Aussie Sport | Ibramed Equipamentos Médicos | | Secondary<br>Predicate | K031077 | Vectra Genesis | Chattanooga | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for IBRAMED. The logo consists of a stylized symbol above the word "IBRAMED". The symbol is made up of two blue curved shapes on the top and bottom, with a black hourglass shape in the middle. The word "IBRAMED" is written in a bold, sans-serif font. Ibramed Equipamentos Médicos Av. Dr. Carlos Burgos, 2800 - Jardim Itália, Amparo - SP, 13901-080 Brazil Ph: + 55 19 3817 9633 ## I) Indications for Use ## 1. Subject device: Neurodyn V2.0, Neurodyn Aussie V2.0 ### Neurodyn V2.0 Stimulators are intended for: 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 As a High Voltage Pulsed current device: - Muscle re-education - Relaxation of Muscle Spasms - Maintaining or increasing range of motion - Increasing local blood circulation - Prevention or retardation of disuse atrophy ## Neurodyn Aussie V2.0 Stimulators are intended for: As a Burst Modulated Alternating Current (Aussie) device: - Temporary relaxation of muscle spasms - Prevention or retardation of disuse atrophy in post-injury type conditions {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for IBRAMED. The logo features a stylized symbol above the word "IBRAMED". The symbol consists of two blue shapes that resemble stylized wings or curved lines, positioned above and below a black hourglass shape. The word "IBRAMED" is written in a bold, sans-serif font, with the letters in black. lardim Itália - Increase local blood circulatio - 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 ### 2. Predicate: Neurodyn Multiwave; Neurodyn Aussie Sport ### 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 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 {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for IBRAMED. The logo consists of a stylized blue and black symbol above the word "IBRAMED" in black, bold letters. The symbol is composed of two blue shapes that resemble open books facing each other, connected by a black hourglass shape in the center. Ibramed Equipamentos Médicos Av. Dr. Carlos Burgos, 2800 - Jardim Itália, Amparo - SP, 13901-080 Brazil Ph: + 55 19 3817 9633 - Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain ## 3. Secondary Predicate Device: Vectra Genesis Indications for Use for High Voltage current device: - Muscle re-education - Relaxation of Muscle Spasms - Maintaining or increasing range of motion - Increasing local blood circulation - Prevention or retardation of disuse atrophy {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Ibramed. The logo consists of a stylized blue and black symbol to the left of the word "IBRAMED" in black, bold letters. To the right of the logo is the text "Ibramed Equip", "Av. Dr. Carlos", "Amparo - SP,", and "Ph: + 55 19 3". Ibramed Equipamentos Médicos gos, 2800 - Jardim Itália, 1-080 Brazil #### K) Technological Characteristics Comparison: The predicate device used to establish squivalence for the Neurodyn Aussie V2.0 device is outlined below. This section of this submission will provide a comparison of dechnical specifications of the Neurodyn V2.0 to each of the predicate devices stratified by functional modality. | Device name | Neurodyn_V2.0;<br>Neurodyn Aussie_V2.0 | Neurodyn Multiwave;<br>Neurodyn Aussie Sport | Vectra Genesis | SE Discussion of the<br>differences | |-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K Number | K210572 | K131629 | K031077 | N/A | | Manufacturer | Ibramed | Ibramed | Chattanooga | N/A | | Population target | Patients must be at least<br>12 years of age and<br>Patients must weigh at<br>least 35 kg. | Patients must be at least<br>12 years of age and<br>Patients must weigh at<br>least 35 kg. | Not stated in the Manual | Identical when compared<br>with Neurodyn | | Environment | Hospitals, Clinics, o<br>medical environment | Hospitals, Clinics, o<br>medical environment | Hospitals, Clinics, o<br>medical environment | Identical | | Technological<br>characteristics Medium-<br>frequency alternating<br>current (MFAC) | Identical | Identical | Similar | N/A | | Housing Material | ABS plastic panel LCD<br>display | ABS plastic panel LCD<br>display | Not stated in the Manual | N/A | | Dimensions W x H x D<br>(in) | Neurodyn V2.0 14.6 x 4.9<br>x 12.4<br>Aussie: 10.6 x 4.9 x 10.4 | 6.8 x 4.9 x 12.4 | 11.38 x 8.75 x 12.75 | N/A | | Weight | 5Lb | 5Lb | 7Lb | N/A | | Number of Channels | Up to 4 | Up to 4 | Up to 4 | Identical | | Temperature range<br>during transport and<br>storage | 41°F-122°F | 41°F-122°F | 59° F and 104° F | The ranges are very<br>similar not affecting the<br>substantial equivalence. | | Environment operating<br>temperature range | 41°f-113°f | 41°F-113°F | No specified | The ranges are very<br>similar not affecting the<br>substantial equivalence. | | Performance | Identical | Identical | Identical | Identical | | Biocompatibility | FDA cleared electrodes | FDA cleared electrodes | FDA cleared electrode | Identical | | Mechanical safety | Identical | Identical | Identical | Identical | | Anatomical Sites | Identical | Identical | Similar | N/A | | Burst Modulated<br>Alternating Current<br>( Russian ) | Yes | Yes | Yes | Identical | | Burst Modulated<br>Alternating Current<br>(Aussie) | Yes | Yes | No | Vectra does not have the<br>Aussie current but the<br>Neurodyn contains,<br>supporting the<br>substantial equivalence. | | Interferential | Yes | Yes | Yes | Identical | | Microcurrent | Yes | Yes | Yes | Identical | | TENS | Yes | Yes | Yes | Identical | | FES | NEURODYN_V2.0: Yes<br>NEURODYN AUSSIE_V2.0:<br>No | Yes | No | Vectra does not have the<br>FES current but the<br>Neurodyn contains,<br>supporting the<br>substantial equivalence. | | Premodulated | Yes | Yes | Yes | Identical | | High Volt | Yes | No | Yes | Neurodyn does not have<br>the HV current but the<br>Vectra contains, | | | | | | supporting the<br>substantial equivalence. | | Method of current<br>isolation | Double Isolation | Double Isolation | Double Isolation | Identical | | Patient leakage control-<br>normal condition | NEURODYN_V2.0: 0.0044<br>mA<br>NEURODYN AUSSIE_V2.0:<br>0.0134 mA | 0.0508mA | 100µA | It is between the<br>standard acceptance<br>range, supporting the<br>substantial equivalence. | | Patient leakage control-<br>single fault condition | NEURODYN_V2.0: 0.0124<br>mA<br>NEURODYN AUSSIE_V2.0:<br>0.0008 mA | 0.0252mA | 500µA | It is between the<br>standard acceptance<br>range, supporting the<br>substantial equivalence. | | Number of output mode | NEURODYN_V2.0: 8<br>NEURODYN AUSSIE_V2.0:<br>1 | 7 | 10 | Number of modalities<br>that the equipment<br>provides, the modalities<br>are independent and do<br>not need each other to<br>carry out the treatment,<br>limiting only the number<br>of treatments performed<br>according to the supplied<br>currents. | | Synchronous or<br>Alternating? | Synchronous | Synchronous | Synchronous | Identical | | Method of Channel<br>isolation | Output transformation with<br>isolation to 1000V | Output transformation<br>with isolation to 1000V | Not Stated in the Manual | Identical when compared<br>with Neurodyn | | Regulated current or<br>regulated voltage? | Only Current | Only Current | Optional | Circuit regulated in<br>current or voltage does | | | | | Current or Voltage | not interfere in<br>performance, but circuit<br>regulated in current is<br>more common. | | Software Microprocessor | Yes | Yes | Yes | Identical | | Automatic overload trip | No | No | Not Stated in the Manual | Identical when compared<br>with Neurodyn | | Automatic no-load trip | No | No | Not Stated in the Manual | Identical when compared<br>with Neurodyn | | Automatic shut off | Yes | Yes | Yes | Identical | | Patient override control? | Yes | Yes | Yes | Identical | | Indicator Display<br>On/off Status? | Yes | Yes | Yes | Identical | | Indicator Display<br>Voltage/Current Level? | NEURODYN_V2.0: Aussie 0<br>to 120mA (Ipp)<br>NEURODYN AUSSIE_V2.0:<br>Aussie 0 to 120mA (Ipp) | Aussie 0 to 120mA (Ipp) | No | Identical when compared<br>with Neurodyn | | | NEURODYN_V2.0: Russa 0<br>to 120mA (Ipp) | Russa 0 to 120mA (Ipp) | Russian 0 to 100 mA | Characteristics of the<br>circuit, does not interfere<br>in the performance, since<br>the intensity does not<br>have fixed parameter, it<br>is according to the<br>sensorial of each patient. | | | NEURODYN_V2.0: TENS 0<br>to 120mA (Ipp) | TENS 0 to 120mA (Ipp) | Tens 0 to 80 mA | Characteristics of the<br>circuit, does not interfere<br>in the performance, since<br>the intensity does not | | NEURODYN_V2.0: FES 0 to<br>120mA (Ipp) | FES 0 to 120mA (Ipp) | No | have fixed parameter, it<br>is according to the<br>sensorial of each patient.<br>Identical when compared<br>with Neurodyn | | | NEURODYN_V2.0:<br>Interferential TP 0 to<br>120mA (Ipp) | Interferential TP 0 to<br>120mA (Ipp) | Interferential 0 to 100<br>mA | Characteristics of the<br>circuit, does not interfere<br>in the performance, since<br>the intensity does not<br>have fixed parameter, it<br>is according to the<br>sensorial of each patient. | | | NEURODYN_V2.0:<br>Interferential BP 0 to<br>120mA (Ipp) | Interferential BP 0 to<br>120mA (Ipp) | Interferential 0 to 100<br>mA | Characteristics of the<br>circuit, does not interfere<br>in the performance, since<br>the intensity does not<br>have fixed parameter, it<br>is according to the<br>sensorial of each patient. | | | NEURODYN_V2.0: Micro<br>Current 0 to 990μA (Ip) | Micro Current 0 to 990µA<br>(Ip) | Micro Current 0 to 100 µA | Characteristics of the<br>circuit, does not interfere<br>in the performance, since<br>the intensity does not<br>have fixed parameter, it<br>is according to the<br>sensorial of each patient. | | | NEURODYN_V2.0:<br>Polarized/ Direct Current 0<br>to 30 mA (Ip) | Polarized/ Direct Current<br>0 to 30 mA (Ip) | Direct Current 0 to 4 mA | Characteristics of the<br>circuit, does not interfere<br>in the performance, since<br>the intensity does not<br>have fixed parameter, it<br>is according to the | | | | | | | is according to the<br>sensorial of each patient. | | | High Volt 0 to 400 V | | High Volt 0 to 500V | Characteristics of the<br>circuit, does not interfere<br>in the performance, since<br>the intensity does not<br>have fixed parameter, it<br>is according to the<br>sensorial of each patient. | | Locking feature | Keyboard lock safety<br>feature | Keyboard lock safety<br>feature | Keyboard lock safety<br>feature | Identical | | Treatment timer | Treatment timer with auto<br>shut off 1-60 minutes | Treatment timer with auto<br>shut off 1-60 minutes | Treatment timer with auto<br>shut off 1-60 minutes | Identical | | Voltage Input Range and<br>Frequency | 100-240VAC, 50/60Hz | 100-240VAC, 50/60Hz | 100-240VAC, 50/60Hz | Identical | | Safety standards<br>requirements<br>biocompatibility | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10<br>21 CFR 898 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10<br>21 CFR 898 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10<br>21 CFR 898 | Identical | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for IBRAMED. The logo consists of a stylized symbol in black, resembling two connected hourglass shapes, positioned above the text "IBRAMED" in a bold, sans-serif font. The symbol is flanked by two blue shapes that curve inward, creating a symmetrical design. The overall impression is modern and professional. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for IBRAMED. The logo consists of a stylized symbol above the word "IBRAMED". The symbol is composed of three blue shapes on the top and three blue shapes on the bottom, with a black shape in the middle. The word "IBRAMED" is in a bold, sans-serif font. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for IBRAMED. The logo consists of a stylized blue and black graphic above the word "IBRAMED" in black, sans-serif font. The graphic resembles a bow tie or a stylized hourglass shape, with three horizontal blue bars on the top and bottom, and a black vertical bar in the center. {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logo for IBRAMED. The logo consists of a stylized blue and black design above the word "IBRAMED" in black, bold letters. The design features two sets of curved blue shapes on the top and bottom, with a black hourglass shape in the center. Ibramed Equipamentos Médicos Av. Dr. Carlos Burgos, 2800 - Jardim Itália, Amparo - SP, 13901-080 Brazil Ph: + 55 19 3817 9633 {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the logo for IBRAMED. The logo consists of a stylized blue and black graphic above the word "IBRAMED" in black, sans-serif font. The graphic resembles a bow tie or a stylized hourglass shape, with three horizontal blue bars on the top and bottom, and a black vertical bar in the center. Conclusion: The Neurodyn V2.0 device and the predicate devices are substantially equivalent when comparing the indications for use, and technological properties. The differences shown in the comparison do not affect the substantial equivalence. {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the logo for Ibramed. The logo consists of a stylized blue and black symbol to the left of the word "IBRAMED" in blue. To the right of the logo is the text "Ibramed" followed by an address and phone number, beginning with "Ph: + 55". bramed Equipamentos Médicos Carlos Burgos, 2800 - Jardim Itália, 3901-080 Brazil า: + 55 19 3817 9633 ## L) Applicable Standards: Neurodyn V2.0 was developed, as well produced in compliance with recognized international regulations and standards for the medical device industry. IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests IEC 60601-2-10 - Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators ## Conclusion: Based on compliance with the international standard and regulation mentioned above, the device Neurodyn V2.0 demonstrate substantial equivalence to the predicates above. {15}------------------------------------------------ Image /page/15/Picture/0 description: The image shows the logo and contact information for Ibramed Equipamentos Médicos. The logo features a stylized blue and black design with the word "BRAMED" underneath. The contact information includes the address "Av. Dr. Carlos Burgos, 2800 - Jardim Itália, Amparo - SP, 13901-080 Brazil" and the phone number "Ph: + 55 19 3817 9633". ## M) Non-clinical Testing: In order to study the performance of the product, pre-clinical tests were performed according to the table below. #### Test Performance IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 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 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests Conclusion: Based on compliance with the international standard and regulation mentioned above, the device Neurodyn V2.0 demonstrates equivalency to the predicate device.