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 Description

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 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 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.

AI/ML Overview

The provided text is a 510(k) summary for the MyndMove and MyndMove 2.0 electrical stimulation devices. It aims to demonstrate substantial equivalence to previously cleared predicate devices (MyndMove K170564 and MyndMove 2.0 K212149).

The key takeaway is that no new acceptance criteria, performance studies, or clinical data were generated or required for this 510(k) submission (K233006). The submission explicitly states: "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)."

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this specific submission (K233006) refer to the previously established criteria and studies for the predicate devices. The document essentially argues that since the new submission's devices are identical in technological characteristics and therapy protocols to the cleared predicates, they inherently meet the acceptance criteria validated by the predicate studies.

However, to answer your request fully, I will extrapolate the "acceptance criteria" and "reported device performance" based on the "Substantial Equivalence Discussion" table, which compares the subject devices (MyndMove and MyndMove 2.0) to their predicates across various technical specifications. The acceptance criteria, in this context, are the specifications of the predicate devices that the subject devices are claiming to be identical to.

1. Table of Acceptance Criteria and the Reported Device Performance

Since the submission explicitly states there are no changes to the technological characteristics of MyndMove or MyndMove 2.0, the "reported device performance" for the subject devices (MyndMove and MyndMove 2.0 in K233006) is asserted to be identical to the predicate devices. The "acceptance criteria" are the specifications of the predicate devices.

Feature / Acceptance Criteria (from Predicate Device)	Reported Device Performance (MyndMove & MyndMove 2.0 in K233006)	SE Comparison
Indications for Use: FES for improvement of arm/hand function and active ROM in hemiplegia (stroke) or upper limb paralysis (C3-T1 SCI). NMES for general rehabilitation (maintenance/increase ROM, prevention disuse atrophy, increase local blood circulation, reduction muscle spasm, re-education muscles). Administered by trained PT/OT professionals.	Identical to Predicate	Similar (minor wording change for NMES definition)
Anatomical Sites for Stimulation (Upper Limb): Extensor Digitorum, Extensor Carpi Radialis & Ulnaris, Thenar Eminence (Opponens Pollicis Brevis, Flexor Pollicis Brevis & Abductor Pollicis Brevis), Flexor Digitorum Superficialis and Profundus, Biceps, Triceps, Posterior Deltoid, Middle Deltoid, Anterior Deltoid, Pectoralis Major, 1st, 2nd, and 3rd Lumbricals, 2nd Dorsal Interosseous, Serratus Anterior, Lower Trapezius, Upper Trapezius (Scapula).	Identical to Predicate	Identical
Where Used: MyndMove: clinical setting only. MyndMove 2.0: clinical setting and home use by qualified user.	Identical to Predicate	Identical
Regulated current or regulated voltage? Current Regulated	Current Regulated	Identical
Software/firmware/microprocessor control? Yes	Yes	Identical
Automatic overload trip? Yes	Yes	Identical
Automatic no-load trip? Yes	Yes	Identical
Automatic shut off? Yes	Yes	Identical
User override control? Yes	Yes	Identical
Indicator display: Yes (On/off status, Low battery, Voltage/current level)	Yes	Identical
Timer range (minutes): Max duration of stimulation program = 120 minutes (configurable in the backend).	Max duration of stimulation program = 120 minutes (configurable in the backend).	Identical
Compliance with voluntary standards: MyndMove: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10. MyndMove 2.0: ANSI AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10.	Identical to Predicate	Identical
Compliance with 21 CFR 898? Yes	Yes	Identical
Power Sources: MyndMove: Mains OR Rechargeable Li-Ion Battery (specified specs). MyndMove 2.0: AHM100PS24C2-8 manufactured by XP-Power (specified specs), Tripp Lite P012-006.	Identical to Predicate	Identical
Method of line current isolation: Galvanic Isolation (transformer) 4000 VAC	Galvanic Isolation (transformer) 4000 VAC	Identical
Normal condition (uA) (Leakage): Earth Leakage: < 500 uA, Lead to Ground: < 100 uA	Earth Leakage: < 500 uA, Lead to Ground: < 100 uA	Identical
Single fault condition (uA) (Leakage): Earth Leakage: < 1000 uA, Lead to Ground: < 500 uA, Patient on Mains: < 5000 uA	Earth Leakage: < 1000 uA, Lead to Ground: < 500 uA, Patient on Mains: < 5000 uA	Identical
Average DC current through electrodes when device is on but no pulses are being applied (uA): Patient auxiliary current: Normal condition: < 100 uA, Single fault condition: < 500 uA	Patient auxiliary current: Normal condition: < 100 uA, Single fault condition: < 500 uA	Identical
Number of output modes (stimulation protocols): MyndMove: Two Modes (Biphasic Symmetric, Biphasic Asymmetric). MyndMove 2.0: Biphasic Asymmetric.	Identical to Predicate	Identical
Number of output channels: 8	8	Identical
Synchronous or alternating? Asynchronous (channels are staggered)	Asynchronous (channels are staggered)	Identical
Method of channel isolation: Galvanic isolation (transformer): 1500VAC/3kV DC	Galvanic isolation (transformer): 1500VAC/3kV DC	Identical
Weight (Ibs., oz.): 14lbs 6oz.	14lbs 6oz.	Identical
Dimensions (in.) [W x H x D] (including accessories): MyndMove: Stimulator: 9.0 in x 4.3 in x 9.8 in. MyndMove 2.0: Stimulator: L 33 cm x W 25 cm x H 13.5 cm.	Identical to Predicate	Identical
Housing materials and construction: Enclosure = Lexan PCB HPX4R, Plastic Bezel = ABS Plastic, Rubber Membrane = Silicone.	Identical to Predicate	Identical
Additional Features: Timing of stimulation controlled by user via hand or foot switch.	Identical to Predicate	Identical
Design and Human Factors: FES, Single Use Gel Electrodes, 8 stimulation channels (up to 16 electrodes), Controlled by embedded touchscreen GUI and hand/foot switches, Preprogrammed stimulation protocols, No fitting required, instructions for electrode placement included, Used by Clinician Only.	Identical to Predicate	Identical
Biphasic Symmetrical Output Mode (MyndMove only - MyndMove 2.0 N/A):
Waveform: Balanced Biphasic Symmetrical	Balanced Biphasic Symmetrical	Identical
Shape: Rectangular	Rectangular	Identical
Max Output Voltage (+/- 10%) @ 500, 2k, 10kohms: 160V	160V	Identical
Max Output Current (+/- 10%) @ 500, 2k, 10kohms: 20mA (500/2k), 16mA (10k)	20mA (500/2k), 16mA (10k)	Identical
Pulse width: Positive: 150-400 us, Negative: 150-400 us	Positive: 150-400 us, Negative: 150-400 us	Identical
Frequency: 1Hz or 40Hz	1Hz or 40Hz	Identical
Symmetrical phases? Yes	Yes	Identical
Phase Duration: Positive: 150-400 us, Negative: 150-400 us	Positive: 150-400 us, Negative: 150-400 us	Identical
Net Charge (uC per pulse): 2.00 uC	2.00 uC	Identical
Maximum Phase Charge (uC): 9.02 uC	9.02 uC	Identical
Maximum Current Density (RMS) (mA/cm2): 1.36 mA/cm2 (for 1cm x 3cm electrode)	1.36 mA/cm2 (for 1cm x 3cm electrode)	Identical
Maximum Power Density (W/cm2): 0.044W/cm2	0.044W/cm2	Identical
Burst Mode (Pulses per burst, Bursts per second, Burst duration, Duty Cycle): Not Applicable, No Burst Mode	Not Applicable, No Burst Mode	Identical
ON Time (seconds): Not Fixed - User Controlled	Not Fixed - User Controlled	Identical
OFF Time (seconds): Not Fixed - User Controlled	Not Fixed - User Controlled	Identical
Biphasic Asymmetrical Output Mode (MyndMove & MyndMove 2.0):
Waveform: Balanced Biphasic Asymmetrical	Balanced Biphasic Asymmetrical	Identical
Shape: Rectangular	Rectangular	Identical
Max Output Voltage (+/- 10%): Positive: 160V; Negative: 40V	Positive: 160V; Negative: 40V	Identical
Max Output Current (+/- 10%): Positive: 20mA (500/2k), 16mA (10k); Negative: 5mA (500/2k), 4mA (10k)	Positive: 20mA (500/2k), 16mA (10k); Negative: 5mA (500/2k), 4mA (10k)	Identical
Pulse width: Positive: 150-400 us, Negative: 600-1600 us	Positive: 150-400 us, Negative: 600-1600 us	Identical
Frequency: 1Hz or 40Hz	1Hz or 40Hz	Identical
Symmetrical phases? No	No	Identical
Phase Duration: Positive: 150-400 us, Negative: 600-1600 us	Positive: 150-400 us, Negative: 600-1600 us	Identical
Net Charge (uC per pulse): 1.85uC	1.85uC	Identical
Maximum Phase Charge (uC): MyndMove: Positive: 9.02 uC, Negative: 8.86 uC. MyndMove 2.0: 9.02 uC	Identical to Predicate	Identical
Maximum Current Density (RMS) (mA/cm2): MyndMove: 1.07 mA/cm2 (for 1 cm x 3 cm electrodes). MyndMove 2.0: Values for various electrode sizes given.	Identical to Predicate	Identical
Maximum Power Density (W/cm2): 0.044W/cm2	0.044W/cm2	Identical
Burst Mode (Pulses per burst, Bursts per second, Burst duration, Duty Cycle): Not Applicable, No Burst Mode	Not Applicable, No Burst Mode	Identical
ON Time (seconds): Not Fixed - User Controlled	Not Fixed - User Controlled	Identical
OFF Time (seconds): Not Fixed - User Controlled	Not Fixed - User Controlled	Identical

Regarding the Study that Proves the Device Meets the Acceptance Criteria:

The current 510(k) (K233006) for MyndMove and MyndMove 2.0 relies entirely on the previous clearances of K170564 (MyndMove) and K212149 (MyndMove 2.0). The submission explicitly states: "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).". This indicates that the "study" proving the device meets acceptance criteria was performed for the predicate devices. The current submission's argument is based on the substantial equivalence of the subject devices to these previously cleared predicates, meaning they share the same technological characteristics, indications for use, and therapy protocols.

Therefore, the following information relates to the predicate devices' original submissions, as K233006 did not involve new testing. This document does not provide details on the original studies for the predicate devices, but typically such studies would have addressed:

Sample size used for the test set and the data provenance: Not provided in K233006 document. The original predicate submissions (K170564 and K212149) would have outlined any clinical studies, their sample sizes, and whether the data was retrospective or prospective, and its geographical origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in K233006 document. If clinical performance was assessed (likely in the predicate submissions), the ground truth for patient outcomes or assessments would typically be established by qualified medical professionals (e.g., physical therapists, occupational therapists, neurologists), but the specific number and qualifications are not detailed in this current summary.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in K233006 document. This would depend on the nature of any clinical studies for the predicate devices.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable or provided. These devices are functional electrical stimulators for rehabilitation, not imaging analysis tools that typically use MRMC studies with "human readers" and "AI assistance." The "assistance" is the stimulation aiding patient movement, not an AI interpreting medical images.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable in the AI sense. The device requires human professionals (Occupational or Physical Therapy professionals) to administer the therapy, making it a human-in-the-loop system. There's no "algorithm-only" performance for the therapeutic effect. However, the device's software and hardware components would have undergone standalone verification and validation to ensure they meet their design specifications and safety standards as detailed under "Summary of Non-Clinical Testing" (e.g., IEC 62304 for software life cycle processes).
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated for the predicate studies in K233006. For an FES/NMES device, ground truth for clinical effectiveness would typically involve outcomes data such as changes in objective measures of arm/hand function (e.g., Fugl-Meyer Assessment, Action Research Arm Test), active range of motion, muscle strength, and patient-reported outcomes, as assessed by trained therapists or clinicians.
The sample size for the training set: Not provided in K233006 document. If any machine learning components were involved in the development of the predicate devices (which is typical for "coded therapeutic algorithmic protocols"), a training set would have been used. This summary does not give such details.
How the ground truth for the training set was established: Not provided in K233006 document. Similar to point 8, this information would be specific to the development of the predicate devices.

Summary

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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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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 neuromuscularstimulator)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 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.

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.

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:Particular requirements for the basic safety and essential performance of nerveand muscle stimulators.
19-4	ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 andA2:2010/(R)2012 (Consolidated Text): Medical electrical equipment - Part 1:General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD).
19-8	IEC 60601-1-2 Edition 4.0 2014-02: Medical electrical equipment - Part 1-2:General requirements for basic safety and essential performance - CollateralStandard: Electromagnetic disturbances - Requirements and tests.
19-14	IEC 60601-1-11 Edition 2.0 2015-01: Medical electrical equipment - Part 1-11:General requirements for basic safety and essential performance - CollateralStandard: Requirements for medical electrical equipment and medical electricalsystems 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)and Secondary Predicate Device (MyndMove 2.0, K212149)
	Subject Devices(MyndMove and MyndMove 2.0)	Primary Predicate Device(MyndMove)	Secondary Predicate Device(MyndMove 2.0)	SE Comparison
510(k)Number	K233006	K170564	K212149
Indicationsfor Use	MyndMove and MyndMove 2.0 areelectrical stimulation devices indicatedfor the following uses:Functional electrical stimulation (FES)Improvement of arm and hand functionand active range of motion in patientswith hemiplegia due to stroke or upperlimb paralysis due to C3-T1 spinal cordinjury.NeuroMuscular Electrical Stimulation(NMES) for general rehabilitation for:• maintenance and/or increase of armand hand range of motion,• prevention and/or retardation ofdisuse atrophy,• increase in local blood circulation,• reduction in muscle spasm, and• re-education of muscles.MyndMove and MyndMove 2.0 therapiescan only be administered byOccupational or Physical Therapyprofessionals that have completedMyndMove training by MyndTec on theuse of the MyndMove and MyndMove2.0 Systems.	MyndMove is an electrical stimulationdevice indicated for the following uses:Functional electrical stimulation (FES)Improvement of arm and hand functionand active range of motion in patientswith hemiplegia due to stroke or upperlimb paralysis due to C3-T1 spinal cordinjury.NeuroMuscular Electrical Stimulation(NMES)• maintenance and/or increase of armand hand range of motion,• prevention and/or retardation ofdisuse atrophy,• increase in local blood circulation,• reduction in muscle spasm, and• re-education of muscles.MyndMove therapy can only beadministered by Occupational or PhysicalTherapists that have completedMyndMove training by MyndTec on theuse of the MyndMove System.	MyndMove is an electrical stimulationdevice indicated for the following uses:Functional electrical stimulation (FES)Improvement of arm and handfunction and active range of motion inpatients with hemiplegia due to strokeor upper limb paralysis due to C3-T1spinal cord injury.• NeuroMuscular ElectricalStimulation (NMES)• maintenance and/or increase of armand hand range of motion,• prevention and/or retardation ofdisuse atrophy,• increase in local blood circulation,• reduction in muscle spasm, and• re-education of muscles.MyndMove therapy can only beadministered by Occupational orPhysical Therapy professionals thathave completed MyndMove training byMyndTec on the use of the MyndMoveSystem.	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(MyndMove and MyndMove 2.0)	Primary Predicate Device(MyndMove)	Secondary Predicate Device(MyndMove 2.0)	SE Comparison
510(k)Number	K233006	K170564	K212149
AnatomicalSitesforStimulation(Upper Limb)	The MyndMove System stimulates thefollowing Muscles:Extensor Digitorum, Extensor CarpiRadialis & Extensor Carpi UlnarisThenar Eminence (Opponens PollicisBrevis, Flexor Pollicis Brevis & AbductorPollicis Brevis)Flexor Digitorum Superficialis and FlexorDigitorum ProfundusBicepsTricepsPosterior Deltoid, Middle Deltoid, andAnterior DeltoidPectoralis Major1st, 2nd, and 3rd Lumbricals2nd Dorsal InterosseousSerratus Anterior, Lower Trapezius,Upper Trapezius (Scapula)	The MyndMove System stimulates thefollowing Muscles:Extensor Digitorum, Extensor CarpiRadialis & Extensor Carpi UlnarisThenar Eminence (Opponens PollicisBrevis, Flexor Pollicis Brevis &Abductor Pollicis Brevis)Flexor Digitorum Superficialis andFlexor Digitorum ProfundusBicepsTricepsPosterior Deltoid, Middle Deltoid, andAnterior DeltoidPectoralis Major1st, 2nd, and 3rd Lumbricals2nd Dorsal Interosseous	The MyndMove System stimulates thefollowing Muscles:Extensor Digitorum, Extensor CarpiRadialis & Extensor Carpi UlnarisThenar Eminence (Opponens PollicisBrevis, Flexor Pollicis Brevis &Abductor Pollicis Brevis)Flexor Digitorum Superficialis andFlexor Digitorum ProfundusBicepsTricepsPosterior Deltoid, Middle Deltoid, andAnterior DeltoidPectoralis Major1st, 2nd, and 3rd Lumbricals2nd Dorsal InterosseousSerratus Anterior, Lower Trapezius,Upper Trapezius (Scapula).	Identical
Where Used	MyndMove is intended to be used fortherapy sessions in a clinical setting onlyMyndMove 2.0 is intended to be usedfor therapy sessions in a clinical settingand for home use by a qualified user.	Used for therapy sessions in a clinicalsetting only.	Used for therapy sessions in a clinicalsetting and for home use by a qualifieduser.	The subjectMyndMove isidentical to theMyndMovecleared inK170564. ThesubjectMyndMove 2.0 isidentical to the
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(MyndMove and MyndMove 2.0)	Primary Predicate Device(MyndMove)	Secondary Predicate Device(MyndMove 2.0)	SE Comparison
510(k)Number	K233006	K170564	K212149
Regulatedcurrent orregulatedvoltage?	Current Regulated	Current Regulated	Current Regulated	Identical
Software/firmware/microprocessor control?(yes/no)	Yes	Yes	Yes	Identical
Automaticoverloadtrip?(yes/no)	Yes	Yes	Yes	Identical
Automaticno- load trip?(yes/no)	Yes	Yes	Yes	Identical
Automaticshut off?(yes/no)	Yes	Yes	Yes	Identical
User overridecontrol?(yes/no)	Yes	Yes	Yes	Identical
Indicatordisplay:	Yes	Yes	Yes	Identical
- On/offstatus?	Yes	Yes	Yes	Identical
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(MyndMove and MyndMove 2.0)	Primary Predicate Device(MyndMove)	Secondary Predicate Device(MyndMove 2.0)	SE Comparison
510(k)Number(yes/no)	K233006	K170564	K212149
– Lowbattery?(yes/no)	Yes	Yes	Yes	Identical
–Voltage/current level?(yes/no)	Yes	Yes	Yes	Identical
Timer range(minutes)	Stimulation time controlled by user.Max duration of stimulation program =120 minutes (configurable in thebackend)	Stimulation time controlled by user.Max duration of stimulation program =120 minutes (configurable in thebackend)	Stimulation time controlled by user.Max duration of stimulation program =120 minutes (configurable in thebackend)	Identical
Compliancewith voluntarystandards? (ifyes, specify)	MyndMove:IEC 60601-1IEC 60601-1-2IEC 60601-2-10MyndMove 2.0ANSI AAMI ES 60601-1IEC 60601-1-2IEC 60601-2-10	IEC 60601-1IEC 60601-1-2IEC 60601-2-10	ANSI AAMI ES 60601-1IEC 60601-1-2IEC 60601-2-10	The subjectMyndMove isidentical to theMyndMovecleared inK170564. ThesubjectMyndMove 2.0is identical tothe MyndMove2.0 cleared inK212149.
Compliancewith 21 CFR8982 (yes/no)	Yes	Yes	Yes	Identical
Power Sources	MyndMove: Mains OR RechargeableLi-Ion Battery. Rechargeable Li-Ion:14.8 V DC, 2000 mAh Power SupplyInput: 100-240 V AC, 1.2A, 5060 HzPower Supply Output: 24 V DC, 4.16A, 100WMyndMove 2.0: AHM100PS24C2-8manufactured by XP-Power 100-240V AC, 1.2 A, 50-60 Hz 24 V DC, 4.16A, 100 W Tripp Lite P012-006, 1-15Pto C7 -10A, 120V, 18 AWG, 6 ft.,Black Sabic, Lexan Polycarbonate :Sabic, Lexan Polycarbonate Sabic,Lexan Polycarbonate Covestro,Makrolon 2805 Polycarbonate TPEE4001-40-J02	Mains OR Rechargeable Li-Ion Battery.Rechargeable Li-Ion:14.8 V DC, 2000 mAhPower Supply Input: 100-240 V AC,1.2A, 50- 60 HzPower Supply Output: 24 V DC, 4.16 A,100W	AHM100PS24C2-8 manufactured by XP-Power 100-240 V AC, 1.2 A, 50-60 Hz24 V DC, 4.16 A, 100 WTripp Lite P012-006, 1-15P to C7 -10A,120V, 18AWG, 6 ft., BlackSabic, Lexan Polycarbonate: Sabic, Lexan PolycarbonateSabic, Lexan Polycarbonate Covestro,Makrolon 2805 Polycarbonate TPEE4001-40-J02	The subjectMyndMove isidentical to theMyndMovecleared inK170564. ThesubjectMyndMove 2.0is identical tothe MyndMove2.0 cleared inK212149.
Method of linecurrentisolation	Galvanic Isolation (transformer) 4000VAC	Galvanic Isolation (transformer) 4000VAC	Galvanic Isolation (transformer) 4000VAC	Identical
Normalcondition (uA)	Earth Leakage: < 500 uA Lead toGround: < 100 uA	Earth Leakage: < 500 uA Lead toGround: < 100 uA	Earth Leakage: < 500 uA Lead toGround: < 100 uA	Identical
Single faultcondition (uA)	Earth Leakage: < 1000 uA Lead toGround: < 500 uA Patient on Mains:< 5000 uA	Earth Leakage: < 1000 uA Lead toGround: < 500 uA Patient on Mains: <5000 uA	Earth Leakage: < 1000 uA Lead toGround: < 500 uA Patient on Mains: <5000 uA	Identical
Average DCcurrentthroughelectrodeswhen device ison but nopulses arebeing applied(uA)	Patient auxiliary current: Normalcondition: < 100 uASingle fault condition: < 500 uA	Patient auxiliary current: Normalcondition: < 100 uASingle fault condition: < 500 uA	Patient auxiliary current: Normalcondition: < 100 uASingle fault condition: < 500 uA	Identical
Number ofoutput odes(ie. Number ofstimulationprotocols)	MyndMove: Two Modes (applicable toall 33 stimulation protocols):Biphasic SymmetricBiphasic AsymmetricMyndMove 2,0: Biphasic Asymmetric	Two Modes (applicable to all 33stimulation protocols):Biphasic SymmetricBiphasic Asymmetric	Biphasic Asymmetric	The subjectMyndMove isidentical to theMyndMovecleared inK170564. ThesubjectMyndMove 2.0is identical to the MyndMove 2.0 cleared in K170564. The subject MyndMove 2.0
				is identical tothe MyndMove2.0 cleared inK212149.
Number ofoutputchannels	8	8	8	Identical
Synchronous oralternating?	Asynchronous (channels arestaggered)	Asynchronous (channels are staggered)	Asynchronous (channels are staggered)	Identical
Method ofchannelisolation	Galvanic isolation (transformer):1500VAC/3kV DC	Galvanic isolation (transformer):1500VAC/3kV DC	Galvanic isolation (transformer):1500VAC/3kV DC	Identical
Weight (Ibs.,oz.)	14lbs 6oz.	14lbs 6oz.	14lbs 6oz.	Identical
Dimensions(in.) [W x H xD] (includingaccessories)	MyndMove: Stimulator: 9.0 in x 4.3 inx 9.8 inMyndMove 2.0: Stimulator: L 33 cm xW 25 cm x H 13.5 cm	Stimulator: 9.0 in x 4.3 in x 9.8 in	Stimulator: L 33 cm x W 25 cm x H13.5 cm	The subjectMyndMove isidentical to theMyndMovecleared inK170564. ThesubjectMyndMove 2.0is identical tothe MyndMove2.0 cleared inK212149.
Housingmaterials andconstruction(includingaccessories)	Stimulator Housing Materials:Enclosure = Lexan PCB HPX4RPlastic Bezel = ABS PlasticRubber Membrane = Silicone	Stimulator Housing Materials:Enclosure = Lexan PCB HPX4RPlastic Bezel = ABS PlasticRubber Membrane = Silicone	Stimulator Housing Materials:Enclosure = Lexan PCB HPX4RPlastic Bezel = ABS PlasticRubber Membrane = Silicone	Identical
AdditionalFeatures(specify, ifapplicable)	- Timing of stimulation controlled byuser (therapist) through the use of ahand or foot switch	- Timing of stimulation controlled byuser (therapist) through the use of ahand or foot switch	- Timing of stimulation controlled byuser (therapist) through the use of ahand or foot switch	Identical
Design andHuman Factors	Functional Electrical Stimulator.Single Use Gel Electrodes8 stimulation channels, up to 16electrodes.- Controlled by an embedded touchscreen graphical user interface andhand and foot switches.Preprogrammed with stimulationprotocols.- No fitting required, instruction forelectrode placement for eachstimulation protocol included in userinterface.Used by Clinician Only.	Functional Electrical Stimulator.Single Use Gel Electrodes8 stimulation channels, up to 16electrodes.- Controlled by an embedded touchscreen graphical user interface and handand foot switches.Preprogrammed with stimulationprotocols.- No fitting required, instruction forelectrode placement for each stimulationprotocol included in user interface.Used by Clinician Only.	Functional Electrical Stimulator.Single Use Gel Electrodes8 stimulation channels, up to 16electrodes.Controlled by an embedded touchscreen graphical user interface andhand and foot switches.Preprogrammed with stimulationprotocols.No fitting required, instruction forelectrode placement for eachstimulation protocol included userinterface.Used by Clinician Only	Identical
Biphasic Symmetrical Output Mode
Waveform (e.g.Pulsedmonophasic,biphasic)	MyndMove: Balanced BiphasicSymmetricalMyndMove 2.0: Not Applicable, NoSymmetrical Output Mode	Balanced Biphasic Symmetrical	Not Applicable, No Symmetrical OutputMode	The subjectMyndMove isidentical to theMyndMovecleared inK170564. ThesubjectMyndMove 2.0is identical tothe MyndMove2.0 cleared inK212149.
Shape (eg.Rectangular,spike,rectified,sinusoidal)	MyndMove: RectangularMyndMove 2.0: Not Applicable, NoSymmetrical Output Mode	Rectangular	Not Applicable, No Symmetrical OutputMode	The subjectMyndMove isidentical to theMyndMovecleared inK170564. ThesubjectMyndMove 2.0is identical tothe MyndMove2.0 cleared in
				K212149.
MaximumOutputVoltage(volts) (+/-%) at500ohms,2kohms and10kohms	MyndMove: (+/- 10%) @ 500ohms =160V @ 2kohms = 160V @ 10kohms= 160VMyndMove 2.0: Not Applicable, NoSymmetrical Output Mode	(+/- 10%) @ 500ohms = 160V @2kohms = 160V @ 10kohms = 160V	Not Applicable, No Symmetrical OutputMode	The subjectMyndMove isidentical to theMyndMovecleared inK170564. ThesubjectMyndMove 2.0is identical tothe MyndMove2.0 cleared inK212149.
MaximumOutput Current(specify units)(+/- %) at 500ohms, 2kohmsand 10kohms	MyndMove: (+/- 10%) @ 500ohms =20mA @ 2kohms = 20mA @ 10kohms= 16mAMyndMove 2.0: Not Applicable, NoSymmetrical Output Mode	(+/- 10%) @ 500ohms = 20mA @2kohms = 20mA @ 10kohms = 16mA	Not Applicable, No Symmetrical OutputMode	The subjectMyndMove isidentical to theMyndMovecleared inK170564. ThesubjectMyndMove 2.0is identical tothe MyndMove2.0 cleared inK212149.
Pulse width(specifyunits )	MyndMove:Positive: 150-400 usNegative: 150-400 usMyndMove 2.0:Not Applicable, No SymmetricalOutput Mode	Positive: 150-400 usNegative: 150-400 us	Not Applicable, No Symmetrical OutputMode	The subjectMyndMove isidentical to theMyndMovecleared inK170564. ThesubjectMyndMove 2.0is identical tothe MyndMove2.0 cleared inK212149.
Frequency(Hz)	MyndMove: 1Hz or 40HzMyndMove2.0: Not Applicable, NoSymmetrical Output Mode	1Hz or 40Hz	Not Applicable, No Symmetrical OutputMode	The subjectMyndMove isidentical to theMyndMovecleared inK170564. ThesubjectMyndMove 2.0is identical tothe MyndMove2.0 cleared inK212149.
For multiphase waveforms only:
phases?	MyndMove: Yes	Yes	Not Applicable, No Symmetrical Output	The subject
(yes/no)			Mode
Phase Duration(include units),(state range, ifapplicable),(both phases, ifasymmetrical)	MyndMove:Positive: 150-400 usNegative: 150-400 usMyndMove 2.0:Not Applicable, No SymmetricalOutput Mode	Positive: 150-400 usNegative: 150-400 us	Not Applicable, No Symmetrical OutputMode	The subjectMyndMove isidentical to theMyndMovecleared inK170564. ThesubjectMyndMove 2.0is identical tothe MyndMove2.0 cleared inK212149.
Net Charge (uCper pulse) (Ifzero, statemethod ofachieving zeronet charge)	MyndMove: 2.00 uCMyndMove 2.0: Not Applicable, NoSymmetrical Output Mode	2.00 uC	Not Applicable, No Symmetrical OutputMode	The subjectMyndMove isidentical to theMyndMovecleared inK170564. ThesubjectMyndMove 2.0is identical tothe MyndMove2.0 cleared inK212149.
MaximumPhase Charge(uC)	MyndMove: 9.02 uC MyndMove 2.0:Not Applicable, No SymmetricalOutput Mode	9.02 uC	Not Applicable, No Symmetrical OutputMode	The subjectMyndMove isidentical to theMyndMovecleared in
				K170564. ThesubjectMyndMove 2.0is identical tothe MyndMove2.0 cleared inK212149.
MaximumCurrent Density(RMS)(mA/cm2)	MyndMove: 1.36 mA/cm2 (for 1cm x3cm electrode)MyndMove 2.0: Not Applicable, NoSymmetrical Output Mode	1.36 mA/cm2 (for 1cm x 3cm electrode)	Not Applicable, No Symmetrical OutputMode	The subjectMyndMove isidentical to theMyndMovecleared inK170564. ThesubjectMyndMove 2.0is identical tothe MyndMove2.0 cleared inK212149.
MaximumPower Density,(W/cm2),(usingsmallestelectrodeconductivesurface area)	MyndMove: 0.044W/cm2MyndMove 2.0: Not Applicable, NoSymmetrical Output Mode	0.044W/cm2	Not Applicable, No Symmetrical OutputMode	The subjectMyndMove isidentical to theMyndMovecleared inK170564. ThesubjectMyndMove 2.0is identical tothe MyndMove2.0 cleared inK212149.
Burst Mode(i.e., Pulsetrains):	MyndMove: Not Applicable, No BurstModeMyndMove 2.0: Not Applicable, NoSymmetrical Output Mode	Not Applicable, No Burst Mode	Not Applicable, No Symmetrical OutputMode	The subjectMyndMove isidentical to theMyndMovecleared inK170564. ThesubjectMyndMove 2.0is identical tothe MyndMove2.0 cleared inK212149.
Pulses perburst	MyndMove: Not Applicable, No BurstModeMyndMove2.0: Not Applicable, NoSymmetrical Output Mode	Not Applicable, No Burst Mode	Not Applicable, No Symmetrical OutputMode	K212149.The subjectMyndMove isidentical to theMyndMovecleared inK170564. ThesubjectMyndMove 2.0is identical tothe MyndMove2.0 cleared inK212149.
Bursts persecond	MyndMove: Not Applicable, No BurstModeMyndMove2.0: Not Applicable, NoSymmetrical Output Mode	Not Applicable, No Burst Mode	Not Applicable, No Symmetrical OutputMode	The subjectMyndMove isidentical to theMyndMovecleared inK170564. ThesubjectMyndMove 2.0is identical tothe MyndMove2.0 cleared inK212149.
Burst duration(seconds)	MyndMove: Not Applicable, No BurstModeMyndMove2.0: Not Applicable, NoSymmetrical Output Mode	Not Applicable, No Burst Mode	Not Applicable, No Symmetrical OutputMode	The subjectMyndMove isidentical to theMyndMovecleared inK170564. ThesubjectMyndMove 2.0is identical tothe MyndMove2.0 cleared inK212149.
Duty Cycle:	MyndMove: Not Applicable, No Burst ModeMyndMove2.0: Not Applicable, NoSymmetrical Output Mode	Not Applicable, No Burst Mode	Not Applicable, No Symmetrical OutputMode	The subjectMyndMove isidentical to theMyndMovecleared inK170564. ThesubjectMyndMove 2.0is identical tothe MyndMove2.0 cleared inK212149.
Line(b) x Line (c)	Mode		Mode		Mode
	MyndMove2.0: Not Applicable, NoSymmetrical Output Mode				MyndMove isidentical to theMyndMovecleared inK170564. ThesubjectMyndMove 2.0is identical tothe MyndMove2.0 cleared inK212149.
ON Time(seconds)	MyndMove: Not Fixed - UserControlled.MyndMove 2.0: Not Applicable, NoSymmetrical Output Mode	Not Fixed - User Controlled		Not Applicable, No Symmetrical OutputMode	The subjectMyndMove isidentical to theMyndMovecleared inK170564. ThesubjectMyndMove 2.0is identical tothe MyndMove2.0 cleared inK212149.
OFF Time(seconds)	MyndMove: Not Fixed - UserControlledMyndMove 2.0: Not Applicable, NoSymmetrical Output Mode	Not Fixed - User Controlled		Not Applicable, No Symmetrical OutputMode	The subjectMyndMove isidentical to theMyndMovecleared inK170564. ThesubjectMyndMove 2.0is identical tothe MyndMove2.0 cleared inK212149.
Biphasic Asymmetrical Output Mode
Waveform(e.g. Pulsedmonophasic,biphasic)	Balanced Biphasic Asymmetrical	Balanced Biphasic Asymmetrical		Balanced Biphasic Asymmetrical	Identical
	Rectangular	Rectangular	Rectangular	Identical
Shape (e.g.Rectangular,spike, rectifiedsinusoidal)
MaximumOutput Voltage(volts) (+/-%) at500ohms,2kohms and10kohms	(+/- 10%)Positive:@ 500ohms = 160V @ 2kohms =160V @ 10kohms = 160VNegative:@ 500ohms = 40V @ 2kohms = 40V@ 10kohms = 40V	(+/- 10%)Positive:@ 500ohms = 160V @ 2kohms = 160V@ 10kohms = 160VNegative:@ 500ohms = 40V @ 2kohms = 40V @10kohms = 40V	(+/- 10%)Positive:@ 500ohms = 160V @ 2kohms = 160V@ 10kohms = 160VNegative:@ 500ohms = 40V @ 2kohms = 40V @10kohms = 40V	Identical
MaximumOutput Current(specify units)(+/- %) at500 ohms,2kohms and10kohms	(+/- 10%)Positive:@ 500ohms = 20mA @ 2kohms =20mA @ 10kohms = 16mANegative:@ 500ohms = 5mA @ 2kohms = 5mA@ 10kohms = 4mA	(+/- 10%)Positive:@ 500ohms = 20mA @ 2kohms = 20mA@ 10kohms = 16mANegative:@ 500ohms = 5mA @ 2kohms = 5mA @10kohms = 4mA	(+/- 10%)Positive:@ 500ohms = 20mA @ 2kohms =20mA @ 10kohms = 16mANegative:@ 500ohms = 5mA @ 2kohms = 5mA@ 10kohms = 4mA	Identical

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Pulse width(specify units)	Positive: 150-400 usNegative: 600-1600 us	Positive: 150-400 usNegative: 600-1600 us	Positive: 150-400 usNegative: 600-1600 us	Identical
Frequency (Hz)	1Hz or 40Hz	1Hz or 40Hz	1Hz or 40Hz	Identical
For multiphase waveforms only:
Symmetricalphases? (yes/no)	No	No	No	Identical
Phase Duration(include units),(state range, ifapplicable), (bothphases, ifasymmetrical)	Positive: 150-400 usNegative: 600-1600 us	Positive: 150-400 usNegative: 600-1600 us	Positive: 150-400 usNegative: 600-1600 us	Identical
Net Charge (uC perpulse) (If zero,state method ofachieving zero netcharge)	1.85uC	1.85uC	1.85uC	Identical
Maximum PhaseCharge (uC)	MyndMove:Positive: 9.02 uCNegative: 8.86 uCMyndMove 2.0: 9.02 $\mu$ C	Positive: 9.02 uCNegative: 8.86 uC	9.02 $\mu$ C	The subjectMyndMove isidentical to theMyndMovecleared inK170564. ThesubjectMyndMove 2.0 isidentical to theMyndMove 2.0cleared inK212149.
Maximum CurrentDensity (RMS)(mA/cm2)	MyndMove:1.07 mA/cm2 (for 1 cm x 3 cm electrodes)MyndMove 2.0:	1.07 mA/cm2 (for 1 cmx 3 cm electrodes)	Electrode Size: Peak Current/ Imrs (Max): Current Density 1 cm x3 cm 20 mA /2.83 mA 0.93 mA/cm2 2.5 cm Ø 20 mA / 2.83 mA 0.57 mA/cm2 5 cm x5 cm 20 mA / 2.83 mA 0.11 mA/cm2		The subjectMyndMove isidentical to theMyndMovecleared inK170564. The

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	ElectrodeSize:	Peak Current/Imrs (Max):	CurrentDensity
	1 cm x3 cm	20 mA / 2.83 mA	0.93 mA/cm2		9 cm x5 cm	20 mA / 2.83 mA	0.06 mA/cm2	subjectMyndMove 2.0 isidentical to theMyndMove 2.0cleared inK212149.
	2.5 cm Ø	20 mA / 2.83 mA	0.57 mA/cm2
	5 cm x5 cm	20 mA / 2.83 mA	0.11 mA/cm2
	9 cm x5 cm	20 mA / 2.83 mA	0.06 mA/cm2
Maximum PowerDensity, (W/cm2),(using smallestelectrodeconductive surfacearea)	0.044W/cm2			0.044W/cm2				Identical
Burst Mode (ie.Pulse trains):	Not Applicable, No Burst Mode			Not Applicable, No Burst Mode				Identical
Pulses per burst	Not Applicable, No Burst Mode			Not Applicable, No Burst Mode				Identical
Bursts per second	Not Applicable, No Burst Mode			Not Applicable, No Burst Mode				Identical
Burst duration(seconds)	Not Applicable, No Burst Mode			Not Applicable, No Burst Mode				Identical
Duty Cycle: Line(b) x Line (c)	Not Applicable, No Burst Mode			Not Applicable, No Burst Mode				Identical
ON Time (seconds)	Not Fixed - User Controlled			Not Fixed - User Controlled				Identical
OFF Time (seconds)	Not Fixed - User Controlled			Not Fixed - User Controlled				Identical

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Conclusion:

MyndMove and MyndMove 2.0 included in the present submission have the same intended use, output characteristics, and therapy protocols as the predicate devices MyndMove (cleared under K170564) and MyndMove 2.0 (cleared under K212149). The indication for use statement is almost identical to what were cleared in 170564 and K212149 with the exception of a wording change in the Neuromuscular Electrical Stimulation (NMES) that is intended to provide an overall definition for the specific indications (i.e., NMES for general rehabilitation for: maintenance and/or increase of arm and hand range of motion, prevention or retardation of disuse atrophy, increase in local blood circulation, reduction of muscle spasm, re-education of muscles).

In conclusion, the subject MyndMove 2.0 devices are deemed substantially equivalent to the predicate MyndMove and MyndMove 2.0 devices.

Regulation Number and Section

§ 882.5810 External functional neuromuscular stimulator.

(a)
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.(b)
Classification. Class II (performance standards).