VERA

K192474 · Reflexion Health, Inc. · LXJ · Oct 10, 2019 · Physical Medicine

Device Facts

• Record ID: K192474
• Device Name: VERA
• Applicant: Reflexion Health, Inc.
• Product Code: LXJ · Physical Medicine
• Decision Date: Oct 10, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A software system used with the Microsoft Kinect v2 intended to support the physical rehabilitation of adults in the clinic and at home. The system includes rehabilitation exercises for the upper extremity, trunk, and lower extremity with audiovisual feedback & graphic movement representations for patients as well as videos of the patients performing the exercises which can be remotely accessed by the clinician. Patient assessment, exercise guidance and approval by a medical professional is required prior to use.

Device Story

Vera is a software-based physical rehabilitation system utilizing the Microsoft Kinect v2 sensor. It captures patient movement data to provide real-time audiovisual feedback and graphic representations of exercise performance. The system includes a library of exercises for upper extremity, trunk, and lower extremity rehabilitation. Used in both clinical and home environments, it requires initial assessment and exercise prescription by a medical professional. The system records videos of patients performing exercises, which are remotely accessible to clinicians for monitoring and progress tracking. By providing guided exercise and remote oversight, the device aims to support patient adherence to rehabilitation programs and facilitate clinician-led recovery management.

Technological Characteristics

Software system designed for use with Microsoft Kinect v2 sensor; provides audiovisual feedback and graphic movement representation; supports remote clinician access to patient exercise videos.

Indications for Use

Indicated for physical rehabilitation of adults in clinical or home settings. Requires prior assessment, guidance, and approval by a medical professional.

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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October 10, 2019

Reflexion Health, Inc. Walter Cordiglia Chief Compliance Officer 225 Broadway Ste. 300 San Diego, California 62101

Re: K192474

Trade/Device Name: Vera Regulation Number: 21 CFR 890.5360 Regulation Name: Measuring Exercise Equipment Regulatory Class: Class II Product Code: LXJ Dated: September 6, 2019 Received: September 10, 2019

Dear Walter Cordiglia:

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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Vivek Pinto, Ph.D. 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

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## Indications for Use

510(k) Number (if known) K192474

Device Name VERA

## Indications for Use (Describe)

A software system used with the Microsoft Kinect v2 intended to support the physical rehabilitation of adults in the clinic and at home. The system includes rehabilitation exercises for the upper extremity, trunk, and lower extremity with audiovisual feedback & graphic movement representations for patients as well as videos of the patients performing the exercises which can be remotely accessed by the clinician. Patient assessment, exercise guidance and approval by a medical professional is required prior to use.

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

| <div> <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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