MindMotion(TM) GO

K173931 · Mindmaze SA · LXJ · May 17, 2018 · Physical Medicine

Device Facts

• Record ID: K173931
• Device Name: MindMotion(TM) GO
• Applicant: Mindmaze SA
• Product Code: LXJ · Physical Medicine
• Decision Date: May 17, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MindMotion™ GO is a medical device software used in combination with the Microsoft Kinect v2 and Leap Motion controller that supports the physical rehabilitation of adults in the clinic and at home. The software includes rehabilitation exercises for the upper extremity, trunk, and lower extremity; audio-visual feedback and graphic movement representations for patients; and patient performance metrics for the medical professional. Patient assercise guidance, and approval by the medical professional is required prior to use.

Device Story

MindMotion™ GO is a software-based rehabilitation system utilizing Microsoft Kinect v2 and Leap Motion controller sensors to track patient movement. It provides interactive rehabilitation exercises for upper extremity, trunk, and lower extremity. The system transforms sensor input into real-time audio-visual feedback and graphic representations of movement for the patient. It generates performance metrics for medical professionals to monitor progress. Used in clinics or home environments under professional supervision; requires clinician approval and guidance. Benefits include structured physical therapy engagement and objective tracking of patient performance.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Software-based system; utilizes external sensors (Microsoft Kinect v2, Leap Motion controller); provides audio-visual feedback and performance metrics; intended for adult physical rehabilitation.

Indications for Use

Indicated for physical rehabilitation of adults in clinical or home settings. Requires medical professional guidance and approval prior to use.

Regulatory Classification

Identification

Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.

Special Controls

*Classification.* Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 17, 2018

MindMaze SA Sylvian Bourriquet Director, Quality and Regulatory Affairs Chemin de Roseneck 5 Lausanne, CH-1006 Switzerland

Re: K173931

Trade/Device Name: MindMotion™ GO Regulation Number: 21 CFR 890.5360 Regulation Name: Measuring Exercise Equipment Regulatory Class: Class II Product Code: LXJ Dated: Not dated Received: May 4, 2018

Dear Sylvian Bourriquet:

We have reviewed vour 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. 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); 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.

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Vivek J. Pinto -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) K173931

Device Name MindMotion™ GO

## Indications for Use (Describe)

MindMotion™ GO is a medical device software used in combination with the Microsoft Kinect v2 and Leap Motion controller that supports the physical rehabilitation of adults in the clinic and at home. The software includes rehabilitation exercises for the upper extremity, trunk, and lower extremity; audio-visual feedback and graphic movement representations for patients; and patient performance metrics for the medical professional. Patient assercise guidance, and approval by the medical professional is required prior to use.

Type of Use (Select one or both, as applicable)

| <span style="font-size:10px"></span> <span style="font-size:10px"> <svg height="10" width="10"> <rect height="10" style="fill:lightgrey;stroke-width:1;stroke:rgb(0,0,0)" width="10"></rect> <line style="stroke:rgb(0,0,0);stroke-width:1" x1="0" x2="10" y1="0" y2="10"></line> <line style="stroke:rgb(0,0,0);stroke-width:1" x1="0" x2="10" y1="10" y2="0"></line> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
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| <span style="font-size:10px"></span> <span style="font-size:10px"> <svg height="10" width="10"> <rect height="10" style="fill:lightgrey;stroke-width:1;stroke:rgb(0,0,0)" width="10"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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