Neuro20 Pro System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 23, 2023 Neuro20 Technologies % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059 Re: K223797 Trade/Device Name: Neuro20 Pro System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX, IPF Dated: January 25, 2023 Received: February 6, 2023 Dear Dave Yungvirt: 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. {1}------------------------------------------------ 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 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 medical devices and radiation-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. # Tushar Bansal -S Tushar Bansal, PhD Acting Assistant Director, Acute Injury Devices Team 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) K223797 Device Name Neuro20 PRO System #### Indications for Use (Describe) The Neuro20 PRO System is intended to stimulate muscles in order to improve or facilitate muscle performance. Other indications for use include: - · Re-educating muscles - · Increasing local blood circulation - · Maintaining or increasing range of motion - · Relaxation of muscle spasm - · Retarding or preventing disuse atrophy 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Neuro20 Efficient Health. The word "NEURO" is in a bold, sans-serif font, with the "20" in a smaller, lighter font to the right. There is a graphic of connected dots to the left of the "20". Below the word "NEURO" is the phrase "EFFICIENT HEALTH" in a smaller, lighter font. ## 510(k) Summary | 510(k) Submitter: | Dennis Schmitt<br>Neuro20 Technologies, Corp.<br>3802 Spectrum Blvd<br>Suite 116E<br>Tampa, FL 33612<br>(917) 503 NURO (6876)<br>dj@neuro20.com | |----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Primary Correspondent: | Dennis Schmitt<br>Neuro20 Technologies, Corp.<br>3802 Spectrum Blvd<br>Suite 116E<br>Tampa, FL 33612<br>(917) 503 NURO (6876)<br>dj@neuro20.com | | Date 510(k) Summary Prepared | 15-July-2022 | | Trade Name of Device:<br>Common Name:<br>Model Identification:<br>Product codes:<br>Classification Name: | Neuro20 PRO System<br>Neuro20 PRO<br>N20PRO-SYS<br>NGX, IPF<br>Stimulator, Muscle, Powered, For Muscle Conditioning<br>(21CFR 890.5850, Product Code NGX)<br>Stimulator, Muscle<br>(21CFR 890.5850, Product Code IPF) | | Review Panel | 89 Physical Medicine | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Neuro20. The word "NEURO" is in a bold, sans-serif font, with the "20" in a lighter, sans-serif font to the right. To the left of the "20" is a graphic of connected dots. Below the word "NEURO" is the phrase "EFFICIENT HEALTH" in a smaller, sans-serif font. ### Predicate devices | Primary Predicate Device: | miha bodytec II | |-----------------------------|-------------------------------------------------------------------| | 510(k) Number: | K201975 | | Product Classification: | II | | Classification Name: | Powered Muscle Stimulator (21CFR 890.5850, Product Code NGX, IPF) | | Secondary Predicate Device: | Compex® Rehab | | 510(k) Number: | K090632 | | Product Classification: | II | | Classification Name: | Powered Muscle Stimulator (21CFR 890.5850, Product Code IPF) | #### Device Description: The Neuro20 PRO System is a powered muscle stimulator designed for individual or group rehabilitation and recovery. The Neuro20 PRO System is a transcutaneous electrical muscle stimulation (EMS) device which stimulates motor nerves by means of electrical impulses transmitted by electrodes. The system utilizes electrical stimulation to create an involuntary contractions of motor neurons are transmitted to the muscle fibers where they stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse intensity, pulse duration, pulse width, pulse rise, pause time, total session duration), different types of muscle work can be imposed on the stimulated muscles. The involuntary muscle activation can be voluntarily over-ridden through intentional exercise. Individual intensity levels can be modulated for each muscle group. One to ten patients may be treated within a session. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image is a logo for Neuro20 Efficient Health. The logo has the word "NEURO" in bold, black letters. To the right of the word "NEURO" is the number "20" in a light blue color. There are also some light blue and black dots and lines that connect the word "NEURO" to the number "20". Below the word "NEURO" is the phrase "EFFICIENT HEALTH" in light blue letters. ### Device Description (continued) The Neuro20 PRO System is comprised of three major components: the Control Box with battery (the muscle stimulator), Smart Suit (the wearable suit with electrodes covering the muscles), and Operating Tablet with software which allows the medical professional to adjust the parameters for the patient. Users may be actively engaged within a variety of training modes while the clinician/operator controls the software. The Neuro20 PRO System accessories are a battery charger, protective case, and Smart Suit packaging. The Neuro20 Control Box connects to the suit and is powered by a battery. It is controlled by the medical practitioner operating the software. The Smart Suit applies the electrodes to the upper body, arms, legs, and buttocks. The Control Unit is connected to the Operating Tablet wirelessly. The Neuro20 PRO System is to be used in a professional setting such as physicians' office, physical therapist, professional sports setting, and nursing homes as well as in the home healthcare environment. The device must be operated by a trainer who has received full training from the manufacturer. Prior to a training session the correct suit size is selected for the patient in order to ensure proper placement of the electrodes. The trainer can choose between pre-set training programs on the software. The intensity can be adjusted by the trainer at the UI of the Operating Tablet separately for each channel. Complete body training which addresses all muscle groups is possible with up to 10 pairs of electrodes. Once the training is started, the control unit generates and transmits the electrical signals to the electrodes via Bluetooth. During pulse application, the trainer instructs the patient on specific exercises to perform. The training can be stopped anytime by pressing the multi-function / stop button, pause button on the software, or on the Control Box connected to the Suit. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a logo for Neuro20. The logo has the word "NEUR" in black, with the "20" in blue and a graphic of connected dots to the left of the "20". Below the logo is the phrase "EFFICIENT HEALTH" in blue. ## Indications for Use of the Device: The Neuro20 PRO System is intended to stimulate muscles in order to improve or facilitate muscle performance. Other indications for use include: - Re-educating muscles - Increasing local blood circulation - Maintaining or increasing range of motion - Relaxation of muscle spasm - Retarding or preventing disuse atrophy The following table compares the indications for use of the proposed device against those of the primary predicate device and the secondary predicate device. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image is a logo for Neuro20 Efficient Health. The word "NEURO" is in large, bold, black letters. To the right of the word "NEURO" is a graphic of blue and black dots and lines, followed by the number "20" in blue. Below the word "NEURO" is the phrase "EFFICIENT HEALTH" in smaller, blue letters. #### Technological Characteristics Comparison with Predicates: The design and material differences between the Neuro20 PRO System, the primary predicate and secondary predicate is that the Neuro20 PRO System design is a complete body suit made of flexible spandex with electrodes that do not contain accessible plugs or cables but does contain a battery pack with rechargeable Bluetooth technology. The miha bodytec II uses external power supply to operate and involves the use of an ibody® electrode polyurethane vest worn by the patient, with electrodes worn over under garments and a control unit mounted on a stand, connected with the control unit via cables. The Compex® Rehab is a battery-powered hand-held stimulator which connects to cutaneous electrodes, placed manually on the body part being targeted (including the same body parts as those targeted by the Neuro20 PRO System and miha bodytec II). In summary for energy comparison between the Neuro20 PRO System, the primary predicate and secondary predicate, and miha bodytec II, the Neuro20 PRO has less maximum output voltage, output current, power density and phase charge than the primary predicate and secondary predicate miha bodytec II. The Neuro20 PRO system is within the pulse width, pulse frequency, and pulse duration range of the primary predicate and secondary predicate. miha bodytec II . The waveforms of the Neuro20 PRO System, the primary predicate and secondary predicate and the miha bodytec II are similar. The Neuro20 PRO System has more safety options then the primary predicate and secondary predicate miha bodytec II in that the Neuro20 PRO System connector layout is designed to prevent misconnection, current regulation, no charging of the device is possible while training (removal of accumulator), fuses and lock bits against manipulation, battery, voltage, and output current monitoring. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Neuro20. The logo has the word "NEURO" in black, with the number "20" in blue and black to the right of the word. Below the word "NEURO" is the phrase "EFFICIENT HEALTH" in blue. # Technological Characteristics Comparison with Predicates: (continued) | Characteristic | Neuro20 PRO System<br>Proposed device | miha bodytec II<br>Primary predicate | Compex® Rehab<br>Secondary predicate | |------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. 510(k) Number | K223797 | K201975 | K090632 | | 2. Device Name, Model | Neuro20 PRO System | miha bodytec II | Compex® Rehab | | 3. Manufacturer | Neuro20 Technologies, Corp. | miha bodytec GmbH | Chattanooga Group | | 4. Power Source(s) | Rechargeable Li-ion battery 7.4V Types LP-E5, 2 Cells each UL listed: MH60905. Pack certified to IEC62133-2:2017 (5.6 watts (756 mA Max @ 7.4 V). | Control Unit: 15V – 19V; External power supply (100-240V ~ 50-60 Hz). | 4.8 V (2000 mAh) NiMH rechargeable battery | | - Method of Line Current Isolation | N/A – Neuro20 PRO System is a battery-operated device in accordance with 60601-1-1 | Power Supply in accordance with IEC 60601-1-1 | N/A (battery operated device) | | - Patient Leakage<br>-- Normal Condition<br>-- Single Fault Condition | N/A – Neuro20 PRO System is a battery-operated device in accordance with 60601-1-1 | < 100 μΑ | N/A (battery operated device) | | 5. Number of Output Modes | 4 output modes | One (symmetric biphasic) with 6 training programs. | One (symmetric biphasic) | | 6. Number of Output Channels | 10 channels selective stimulation. | 10 channels, selective stimulation. Maximum one channel is active at any time. | Four independent and individually adjustable channels that are electrically isolated from each other | | - Synchronous or Alternating | Synchronous, but never two channels activated at the same time. | Alternating. | For 2-channel configuration, channels 1 and 2 alternate. For 4-channel configuration, channels 1+2 alternate with channels 3+4. | | - Method of Channel Isolating | Multiplexed by Control Box | Multiplexed by control unit. | Not publicly available | | 7. Regulated Current or Regulated Voltage? | Constant current control | Regulated voltage (all channels) | Regulated current (all channels) | | Characteristic | Neuro20 PRO System<br>Proposed device | miha bodytec II<br>Primary predicate | Compex® Rehab<br>Secondary predicate | | 8. Software/<br>Firmware/<br>Microprocessor<br>Control | Yes | Yes | Yes | | 9. Automatic<br>Overload Trip | Yes, no load and short<br>circuit conditions are<br>handled | Yes, no load and short<br>circuit conditions are<br>handled | Not publicly available | | 10. Automatic<br>No Load Trip | Yes, no load and short<br>circuit conditions are<br>handled. | Yes, no load and short<br>circuit conditions are<br>handled. | Not publicly available | | 11. Automatic<br>Shut Off | "On/Off" switch and<br>automatic shut off after 4<br>minutes without<br>communication, automatic<br>stop of stimulation in case<br>of failure / malfunction<br>detected | On/Off-Switch, stimulation<br>stops after defined duration,<br>automatic stop of<br>stimulation in case of failure<br>/ malfunction detected. | On/Off button to interrupt<br>the programme<br>momentarily, stimulation<br>stops after defined duration,<br>automatic stop of<br>stimulation in case of failure<br>/ malfunction detected<br>through regular automatic<br>performance checks during<br>operation. | | 12. Patient<br>Override<br>Control | Yes, Stop button located on<br>the Neuro20 Control Box,<br>patient has direct access. | Yes, while a program is<br>active the athlete/patient is<br>supervised by a trainer and<br>able to manipulate intensity<br>(amplitude) and push the<br>stop button. | Operation only by<br>authorized individuals.<br>Choice of therapy<br>parameters, programs and<br>protocols only by<br>responsible physician or<br>therapist. During training<br>not always supervised. Only<br>if patients are unable to<br>operate the emergency stop<br>function. | | 13. Indicator<br>Display:<br>- On/Off Status | Yes | Yes | Yes | | - Low Battery | Yes | N/A - No Battery. | Yes | | - Voltage/<br>Current Level | Yes, displayed in form of<br>percentage / value range. | Yes, displayed in form of<br>percentage / value range. | Yes, displayed in form of<br>black bar graphs | | 14. Timer<br>Range<br>(in minutes) | 5 seconds – 1 hour. Screen<br>shows remaining time in<br>minutes and displays image<br>showing time remaining. | Training should not exceed<br>20 minutes; Screen shows<br>remaining time in minutes<br>and displays image showing<br>time remaining. | Maximum = 20 minutes (for<br>the programs referred to for<br>substantial equivalence<br>discussion); Screen shows<br>remaining time in horizontal<br>bars | | Characteristic | Neuro20 PRO System | miha bodytec II | Compex® Rehab | | | Proposed device | Primary predicate | Secondary predicate | | 15. Compliance | ISO 14971 :2019 | ISO 14971:2007 | IEC 60601-1 | | with Voluntary | IEC 60601-1 2005 | AAMI ANSI ES 60601- | IEC 60601-1-2 | | Standards | +A1 :2012 | 1 2005/®2012 And | IEC 60601-2-10 | | | EN 60601-1-2 : 2020-9 | A1:2012 | | | | FCC/CFR 47 :Part 15B | IEC 60601-1-2:2014 | | | | IEC60601-2- | IEC 60601-1-11:2015 | | | | 10 :2012+AMD1 :2016 | IEC 60601-2-10:2016 | | | | IEC | IEC 62304:2006 + A1:2015 | | | | 62304 :2006+AMD1 :2015 | IEC 62366-1:2015 + | | | | IEC 62366- | COR1:2016 | | | | 1 :2015+AMD1 :2020 | ISO 10993-1:2009 | | | | ISO 10993-1:2018 | ISO 10993-5:2009 | | | | ISO 10993-10:2010 | ISO 10993-10:2010 | | | | IEC 60601-1-6: 2010+AMD | ASTM F1980-16 | | | | 2:2020 | | | | | ISO 15223-1:2016 | | | | | IEC 62133-2:2017 | | | | | IEC 60601-1-11: 2020-7 | | | | | ISO 10993-5: 2009 | | | | | | | | | 16. Compliance | Yes. | Yes. | Yes | | with 21 CFR | | | | | 898 | | | | | 17. Weight | Neuro20 Control Box: 160g | Complete: 45.2 lb Control | Complete: N/A | | | with battery | unit: 10.3 lb i-body® with | Control unit: 0,66 lb | | | Neuro20 Operating Tablet: | cable set: 3.3 lb i-body® | (battery included) | | | Variable. | belt: 0.9 lb i-body® strap: | Accessory: N/A | | | Neuro20 Smart Suit | 0.55 lb | | | | Dependent on clothing size. | | | | 18. Dimensions | Neuro20 Control Box: 126 | Control unit: 1.39 × 0.89 × | Control unit: 0.45 × 0.31 ×…