MyndMove, MyndMove 2.0
Device Facts
| Record ID | K233006 |
|---|---|
| Device Name | MyndMove, MyndMove 2.0 |
| Applicant | Myndtec, Inc. |
| Product Code | GZI · Neurology |
| Decision Date | Jun 25, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
MyndMove and MyndMove 2.0 are electrical stimulation devices indicated for the following uses: Functional electrical stimulation (FES) Improvement of arm and hand function and active range of motion in patients with hemplegia due to stroke or upper limb paralysis due to C3-T1 spinal cord injury. NeuroMuscular Electrical Stimulation (NMES) for general rehabilitation for: - maintenance and/or increase of arm and hand range of motion, - prevention and/or retardation of disuse atrophy, - increase in local blood circulation, - reduction in muscle spasm, and - re-education of muscles. MyndMove and MyndMove 2.0 therapies can only be administered by Occupational or Physical Therapy professionals that have completed MyndMove training by MyndTec on the use of the MyndMove 2.0 Systems.
Device Story
Neuromodulation device delivering electrical pulses to stimulate muscle contractions; enhances motor recovery post-stroke or spinal cord injury. Comprises stimulator, electrodes, cables, hand/foot switches, and integrated software. Used in clinical settings (and home for MyndMove 2.0) by trained therapists. Therapist selects pre-programmed protocols via touch screen UI; customizes intensity. Device connects via IEEE 802.11 wireless to cloud-based backend for patient/protocol management. Patient performs functional tasks while therapist triggers stimulation bursts; provides efferent/afferent input to promote neuroplasticity. Benefits include improved motor function and range of motion.
Clinical Evidence
No clinical data; bench testing only. Device conforms to previously cleared standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, IEC 62304). Biocompatibility of patient-contacting accessories confirmed per ISO 10993-1.
Technological Characteristics
Eight-channel FES/NMES stimulator. Materials: Lexan PCB HPX4R enclosure, ABS plastic bezel, silicone rubber membrane. Output: Current regulated, max 20 mA. Connectivity: IEEE 802.11 a/b/g/n wireless to cloud backend. Power: Mains or 14.8V Li-Ion battery. Galvanic isolation (transformer). Software: Embedded touch screen UI, pre-programmed protocols. Sterilization: N/A (single-use electrodes).
Indications for Use
Indicated for patients with hemiplegia due to stroke or upper limb paralysis due to C3-T1 spinal cord injury. Used for FES to improve arm/hand function and active range of motion, and NMES for general rehabilitation (maintenance/increase of range of motion, prevention/retardation of disuse atrophy, increased local blood circulation, reduction of muscle spasm, muscle re-education). Administered by trained Occupational or Physical Therapy professionals.
Regulatory Classification
Identification
An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.
Predicate Devices
Submission Summary (Full Text)
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June 25, 2024
MyndTec Inc. Yesmil Pena Quality Assurance Manager 1900 Minnesota Court Mississauga, Ontario L5N 3C9 Canada
Re: K233006
Trade/Device Name: MyndMove, MyndMove 2.0 Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI, IPF Dated: May 31, 2024 Received: June 10, 2024
Dear Yesmil Pena:
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
# Amber T. Ballard -S
Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices
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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) K233006
Device Name MyndMove and MyndMove 2.0
#### Indications for Use (Describe)
MyndMove and MyndMove 2.0 are electrical stimulation devices indicated for the following uses:
Functional electrical stimulation (FES)
Improvement of arm and hand function and active range of motion in patients with hemplegia due to stroke or upper limb paralysis due to C3-T1 spinal cord injury.
NeuroMuscular Electrical Stimulation (NMES) for general rehabilitation for:
- · maintenance and/or increase of arm and hand range of motion,
- · prevention and/or retardation of disuse atrophy,
- · increase in local blood circulation,
- · reduction in muscle spasm, and
- · re-education of muscles.
MyndMove and MyndMove 2.0 therapies can only be administered by Occupational or Physical Therapy professionals that have completed MyndMove training by MyndTec on the use of the MyndMove 2.0 Systems.
| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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# 510(k) Summary - K233006
## Submitter / Owner Information
MyndTec Inc. 1900 Minnesota Court, Suite 122 Mississauga, Ontario Canada, L5N 3C9
#### Contact Person
Yesmil Pena Telephone: 905-363-0564 ext. 225 Toll Free: 1-888-363-0581 1-877-796-4624 Fax: yesmil.pena@myndtec.com
#### Date Prepared:
June 21, 2024
#### Device Identification
| A. Proprietary Name | MyndMove and MyndMove 2.0 |
|--------------------------|------------------------------------------------------------------------------------------------------------------|
| B. Device Classification | Class II |
| C. Panel | Neurology |
| D. Device Product Code | GZI and IPF |
| E. Regulation | 21 CFR 882.5810 (External functional neuromuscular<br>stimulator)<br>21 CFR 890.5850 (Powered muscle stimulator) |
#### Identification of Predicate Devices
| Device | Applicant | 510(k) No. | Date Cleared |
|--------------|--------------|------------|-----------------|
| MyndMove | MyndTec Inc. | K170564 | August 30, 2017 |
| MyndMove 2.0 | MyndTec Inc. | K212149 | March 03, 2022 |
## Device Description
The subject devices of K233006 include MyndMove 2.0. There have been no changes to the technological characteristics of MyndMove or MyndMove 2.0 since the clearances of K170564 and K212149.
The MyndMove and MyndMove 2.0 Systems are neuromodulation devices that deliver short electrical pulses to stimulate muscle contractions and enhance motor recovery following Stroke or Spinal Cord Injury. The MyndMove and MyndMove 2.0 systems comprise the Stimulator device, stimulation electrodes and cables, hand and foot switches, and integrated software.
The Functional Electrical Stimulators in the MyndMove 2.0 are eight-channel devices
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with a touch screen user interface (UI). The Stimulator software allows the User to choose from a number of pre-programmed stimulation protocols, to customize the stimulation intensities for each patient, and to document the treatments provided.
Each MyndMove/MyndMove 2.0 Stimulator is connected, via an IEEE 802.11 a/b/g/n wireless radio adapter, to a cloud-based backend data management system. The primary function of the backend is to manage the various elements of the MyndMove 2.0 ecosystem including but not limited to patient unique IDs and prescriptions, therapist profiles and stimulation protocols.
MyndMove and MyndMove 2.0 Therapies can only be administered by trained MyndMove Therapy professionals (TMMT) with assigned Therapist Log-In IDs. TMMTs are Occupational or Physical Therapy professionals that have completed MyndMove training by MyndTec on the use of the MyndMove/MyndMove 2.0 system.
MyndMove and MyndMove 2.0 use surface electrical stimulation to produce muscle contractions in different combinations to achieve a wide range of reaching and grasping functions. To achieve these movements, the single use electrodes are placed in various combinations on the surface of muscles in the arm and hand.
MyndMove and MyndMove 2.0 are based on advanced functional electrical stimulation (FES) principles designed to promote neuroplasticity by influencing the efferent and afferent pathways. Proper sequencing of the muscle contractions as per the MyndMove or MyndMove 2.0 protocols achieve a wide range of functions. During the delivery of MyndMove 2.0 therapy, the patient executes functional tasks with assistance from the MyndMove/MyndMove 2,0 device. The patient attempts to perform the movement and is then assisted to complete the movement when the therapist activates the MyndMove 2.0 stimulation protocol, which generates bursts of short electrical pulses, using surface electrodes, to produce muscle contraction. In this manner, the patient gets both efferent and afferent input as they are actively attempting a movement. Non-damaged pathways can be activated and non-damaged areas of the central nervous system can be trained to substitute for injured areas.
## Indications for Use
MyndMove and MyndMove 2.0 are electrical stimulation devices indicated for the following uses:
Functional electrical stimulation (FES)
Improvement of arm and hand function and active range of motion in patients with hemipleqia due to stroke or upper limb paralysis due to C3-T1 spinal cord injury.
NeuroMuscular Electrical Stimulation (NMES) for general rehabilitation for:
- . maintenance and/or increase of arm and hand range of motion,
- . prevention and/or retardation of disuse atrophy,
- . increase in local blood circulation,
- . reduction in muscle spasm, and
- . re-education of muscles.
MyndMove and MyndMove 2.0 therapies can only be administered by Occupational or Physical Therapy professionals that have completed MyndMove training by MyndTec on the use of the MyndMove and MyndMove 2.0 Systems.
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# Type of Use
Prescription Use (Rx)
## Summary of Non-Clinical Testing
The subject devices conform to all applicable standards listed below, which were leveraged from the previously cleared predicate devices (K170564 and K212149). No additional non-clinical performance testing was conducted because there was no change to the hardware or software since clearances of MyndMove (K170564) and MyndMove 2.0 (K212149).
| FDA Recognition No. | Standard Title |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 17-16 | IEC 60601-2-10 Edition 2.1 2016-04. Medical electrical equipment - Part 2-10:<br>Particular requirements for the basic safety and essential performance of nerve<br>and muscle stimulators. |
| 19-4 | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and<br>A2:2010/(R)2012 (Consolidated Text): Medical electrical equipment - Part 1:<br>General requirements for basic safety and essential performance (IEC 60601-<br>1:2005, MOD). |
| 19-8 | IEC 60601-1-2 Edition 4.0 2014-02: Medical electrical equipment - Part 1-2:<br>General requirements for basic safety and essential performance - Collateral<br>Standard: Electromagnetic disturbances - Requirements and tests. |
| 19-14 | IEC 60601-1-11 Edition 2.0 2015-01: Medical electrical equipment - Part 1-11:<br>General requirements for basic safety and essential performance - Collateral<br>Standard: Requirements for medical electrical equipment and medical electrical<br>systems used in the home healthcare environment. |
| 13-79 | IEC 62304:2006 Medical device software - Software life cycle processes. |
The electrode cables included in the system comply with the U.S. Federal Performance Standard as set forth in 21 CFR 898 for electrode lead wires and Patient Cables. The patient contacting accessories included in the system (the electrodes and security tape) comply with the requirements for biocompatibility (ISO 10993-1).
## Basis for Substantial Equivalence
There have been no changes made to the technological characteristics and therapy protocols of MyndMove or MyndMove 2.0 since their clearance in K170564 or K212149. Both MyndMove and MyndMove 2.0 have the same intended use and deliver functional electrical and neuromuscular stimulation using coded therapeutic algorithmic protocols using an eight- channel stimulator with a maximum 20 mA output current for all 9cm x 5cm, 5cm x 5cm, 2.5cm diameter and 1cm x 3cm single use electrodes. MyndMove and MyndMove 2.0 devices of the present submission have identical technical specifications when compared to previously cleared MyndMove and MyndMove 2.0, as illustrated in the table below.
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| Substantial Equivalence Discussion for Subject Devices (MyndMove and MyndMove 2.0) and Primary Predicate Device (MyndMove, K170564)<br>and Secondary Predicate Device (MyndMove 2.0, K212149) | | | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Devices<br>(MyndMove and MyndMove 2.0) | Primary Predicate Device<br>(MyndMove) | Secondary Predicate Device<br>(MyndMove 2.0) | SE Comparison | |
| 510(k)<br>Number | K233006 | K170564 | K212149 | | |
| Indications<br>for Use | MyndMove and MyndMove 2.0 are<br>electrical stimulation devices indicated<br>for the following uses:<br>Functional electrical stimulation (FES)<br>Improvement of arm and hand function<br>and active range of motion in patients<br>with hemiplegia due to stroke or upper<br>limb paralysis due to C3-T1 spinal cord<br>injury.<br>NeuroMuscular Electrical Stimulation<br>(NMES) for general rehabilitation for:<br>• maintenance and/or increase of arm<br>and hand range of motion,<br>• prevention and/or retardation of<br>disuse atrophy,<br>• increase in local blood circulation,<br>• reduction in muscle spasm, and<br>• re-education of muscles.<br>MyndMove and MyndMove 2.0 therapies<br>can only be administered by<br>Occupational or Physical Therapy<br>professionals that have completed<br>MyndMove training by MyndTec on the<br>use of the MyndMove and MyndMove<br>2.0 Systems. | MyndMove is an electrical stimulation<br>device indicated for the following uses:<br>Functional electrical stimulation (FES)<br>Improvement of arm and hand function<br>and active range of motion in patients<br>with hemiplegia due to stroke or upper<br>limb paralysis due to C3-T1 spinal cord<br>injury.<br>NeuroMuscular Electrical Stimulation<br>(NMES)<br>• maintenance and/or increase of arm<br>and hand range of motion,<br>• prevention and/or retardation of<br>disuse atrophy,<br>• increase in local blood circulation,<br>• reduction in muscle spasm, and<br>• re-education of muscles.<br>MyndMove therapy can only be<br>administered by Occupational or Physical<br>Therapists that have completed<br>MyndMove training by MyndTec on the<br>use of the MyndMove System. | MyndMove is an electrical stimulation<br>device indicated for the following uses:<br>Functional electrical stimulation (FES)<br>Improvement of arm and hand<br>function and active range of motion in<br>patients with hemiplegia due to stroke<br>or upper limb paralysis due to C3-T1<br>spinal cord injury.<br>• NeuroMuscular Electrical<br>Stimulation (NMES)<br>• maintenance and/or increase of arm<br>and hand range of motion,<br>• prevention and/or retardation of<br>disuse atrophy,<br>• increase in local blood circulation,<br>• reduction in muscle spasm, and<br>• re-education of muscles.<br>MyndMove therapy can only be<br>administered by Occupational or<br>Physical Therapy professionals that<br>have completed MyndMove training by<br>MyndTec on the use of the MyndMove<br>System. | Similar | |
| Substantial Equivalence Discussion for Subject Devices (MyndMove and MyndMove 2.0) and Primary Predicate Device (MyndMove, K170564) and Secondary Predicate Device (MyndMove 2.0, K212149) | | | | | |
| | Subject Devices<br>(MyndMove and MyndMove 2.0) | Primary Predicate Device<br>(MyndMove) | Secondary Predicate Device<br>(MyndMove 2.0) | SE Comparison | |
| 510(k)<br>Number | K233006 | K170564 | K212149 | | |
| Anatomical<br>Sites<br>for<br>Stimulation<br>(Upper Limb) | The MyndMove System stimulates the<br>following Muscles:<br>Extensor Digitorum, Extensor Carpi<br>Radialis & Extensor Carpi Ulnaris<br>Thenar Eminence (Opponens Pollicis<br>Brevis, Flexor Pollicis Brevis & Abductor<br>Pollicis Brevis)<br>Flexor Digitorum Superficialis and Flexor<br>Digitorum Profundus<br>Biceps<br>Triceps<br>Posterior Deltoid, Middle Deltoid, and<br>Anterior Deltoid<br>Pectoralis Major<br>1st, 2nd, and 3rd Lumbricals<br>2nd Dorsal Interosseous<br>Serratus Anterior, Lower Trapezius,<br>Upper Trapezius (Scapula) | The MyndMove System stimulates the<br>following Muscles:<br>Extensor Digitorum, Extensor Carpi<br>Radialis & Extensor Carpi Ulnaris<br>Thenar Eminence (Opponens Pollicis<br>Brevis, Flexor Pollicis Brevis &<br>Abductor Pollicis Brevis)<br>Flexor Digitorum Superficialis and<br>Flexor Digitorum Profundus<br>Biceps<br>Triceps<br>Posterior Deltoid, Middle Deltoid, and<br>Anterior Deltoid<br>Pectoralis Major<br>1st, 2nd, and 3rd Lumbricals<br>2nd Dorsal Interosseous | The MyndMove System stimulates the<br>following Muscles:<br>Extensor Digitorum, Extensor Carpi<br>Radialis & Extensor Carpi Ulnaris<br>Thenar Eminence (Opponens Pollicis<br>Brevis, Flexor Pollicis Brevis &<br>Abductor Pollicis Brevis)<br>Flexor Digitorum Superficialis and<br>Flexor Digitorum Profundus<br>Biceps<br>Triceps<br>Posterior Deltoid, Middle Deltoid, and<br>Anterior Deltoid<br>Pectoralis Major<br>1st, 2nd, and 3rd Lumbricals<br>2nd Dorsal Interosseous<br>Serratus Anterior, Lower Trapezius,<br>Upper Trapezius (Scapula). | Identical | |
| Where Used | MyndMove is intended to be used for<br>therapy sessions in a clinical setting only<br>MyndMove 2.0 is intended to be used<br>for therapy sessions in a clinical setting<br>and for home use by a qualified user. | Used for therapy sessions in a clinical<br>setting only. | Used for therapy sessions in a clinical<br>setting and for home use by a qualified<br>user. | The subject<br>MyndMove is<br>identical to the<br>MyndMove<br>cleared in<br>K170564. The<br>subject<br>MyndMove 2.0 is<br>identical to the | |
| Substantial Equivalence Discussion for Subject Devices (MyndMove and MyndMove 2.0) and Primary Predicate Device (MyndMove, K170564)<br>and Secondary Predicate Device (MyndMove 2.0, K212149) | | | | | |
| | Subject Devices<br>(MyndMove and MyndMove 2.0) | Primary Predicate Device<br>(MyndMove) | Secondary Predicate Device<br>(MyndMove 2.0) | SE Comparison | |
| 510(k)<br>Number | K233006 | K170564 | K212149 | | |
| Regulated<br>current or<br>regulated<br>voltage? | Current Regulated | Current Regulated | Current Regulated | Identical | |
| Software/<br>firmware/<br>microprocess<br>or control?<br>(yes/no) | Yes | Yes | Yes | Identical | |
| Automatic<br>overload<br>trip?<br>(yes/no) | Yes | Yes | Yes | Identical | |
| Automatic<br>no- load trip?<br>(yes/no) | Yes | Yes | Yes | Identical | |
| Automatic<br>shut off?<br>(yes/no) | Yes | Yes | Yes | Identical | |
| User override<br>control?<br>(yes/no) | Yes | Yes | Yes | Identical | |
| Indicator<br>display: | Yes | Yes | Yes | Identical | |
| - On/off<br>status? | Yes | Yes | Yes…
