(330 days)
MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) is a powered muscle stimulation system based on electro-myo-stimulation (EMS) technology. It is intended to be used on healthy muscles and clients, not for rehabilitation purposes.
MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. MI.BO. ® MyoBoost EMS System (MB-1000, MB-400) training programs are NOT designed for injured or ailing muscles and its use on such muscles is contraindicated.
The various types of muscle work that the MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) can impose on the stimulated muscles are able to improve or facilitate muscle performance.
MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) is a powered muscle stimulation system based on electro-myo-stimulation (EMS) technology.
This document is a 510(k) clearance letter from the FDA for a powered muscle stimulator. It does not contain information about acceptance criteria or a study proving that an AI/device meets acceptance criteria in the way typically seen for AI/ML-driven medical devices.
The document is for a physical device, the "MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)", which uses electro-myo-stimulation (EMS) technology to stimulate healthy muscles. The FDA's letter is a clearance to market, not a detailed report of a performance study against specific AI/ML acceptance criteria.
Therefore, I cannot provide the requested information as it is not present in the provided text. The questions posed relate to the evaluation of AI/ML algorithms, which is not the subject of this 510(k) clearance.
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April 6, 2021
Arrive Systems Inc % Rhonda Alexander Sr. Consultant, Regulatory Strategy IUVO Consulting, LLC PO Box 56436 Virginia Beach, Virginia 23456
Re: K201257
Trade/Device Name: MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: May 8, 2020 Received: May 11, 2020
Dear Rhonda Alexander:
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 Mav 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (OS) 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.
Jitendra V. Virani -S
Jitendra Virani Acting Assistant Director 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
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Indications for Use
510(k) Number (if known) K201257
Device Name
MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)
Indications for Use (Describe)
MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) is a powered muscle stimulation system based on electro-myo-stimulation (EMS) technology. It is intended to be used on healthy muscles and clients, not for rehabilitation purposes.
MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. MI.BO. ® MyoBoost EMS System (MB-1000, MB-400) training programs are NOT designed for injured or ailing muscles and its use on such muscles is contraindicated.
The various types of muscle work that the MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) can impose on the stimulated muscles are able to improve or facilitate muscle performance.
| 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) |
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§ 890.5850 Powered muscle stimulator.
(a)
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.(b)
Classification. Class II (performance standards).