MyndMove 2.0

K212149 · Myndtec, Inc. · GZI · Mar 3, 2022 · Neurology

Device Facts

• Record ID: K212149
• Device Name: MyndMove 2.0
• Applicant: Myndtec, Inc.
• Product Code: GZI · Neurology
• Decision Date: Mar 3, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

MYNDMOVE is an electrical stimulation device indicated for the following uses: Functional Electrical Stimulation (FES) Improvement of ann and hand functions 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) · Maintenance and/or increase of arm and hand range of motion - · Prevention and/or retardation of disuse atrophy - · Increase in local blood circulation - · Reduction of muscle spasm · Re-education of muscles. Myddlove therapy can only be administered by Occupational or Physical Therapy professionals that have completed MyndMove training by Mynd Tec on the use of the MyndMove System.

Device Story

MyndMove 2.0 is an 8-channel FES/NMES device delivering electrical pulses via surface electrodes to stimulate muscle contractions; promotes neuroplasticity by influencing efferent/afferent pathways. Inputs: pre-programmed stimulation protocols selected via touch screen UI; patient attempts functional tasks while therapist triggers stimulation to assist reaching/grasping. Output: muscle contractions. Used in clinical settings or home environments by trained Occupational/Physical Therapy professionals (or assistants). Cloud-based backend manages patient IDs, prescriptions, and protocols via IEEE 802.11 wireless. Device facilitates motor recovery; patient benefits from active-assisted movement training. Modifications from predicate include removal of internal battery, IP22 ingress protection, optional mobility cart, and added scapula protocols.

Clinical Evidence

No clinical trial data provided. Evidence consists of bench testing and validation on 3 healthy volunteers to confirm scapula protocol efficacy. Bench testing verified compliance with IEC 60601-1, 60601-1-2, 60601-1-11, and 60601-2-10. Electrical output characteristics (net charge per pulse 1.85 µC, max phase charge 9.02 µC) are identical to the predicate.

Technological Characteristics

8-channel FES/NMES stimulator; current-regulated; touch screen UI; IEEE 802.11 wireless connectivity to cloud backend. Materials: Lexan PCB HPX4R enclosure, ABS plastic bezel, silicone membrane. Power: 100-240V AC. Galvanic isolation (4000 VAC). Complies with IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-10. Single-use gel 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 maintenance/increase of range of motion, prevention/retardation of disuse atrophy, increased local blood circulation, reduction of muscle spasm, and muscle re-education.

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

• MyndMove (K170564)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

March 03, 2022

MyndTec Inc. Yesmil Pena Quality Assurance Manager 1900 Minnesota Court Suite 122 Mississauga, Ontario Canada

Re: K212149

Trade/Device Name: MyndMove 2.0 Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI, IPF Dated: January 18, 2022 Received: January 20, 2022

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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

{1}------------------------------------------------

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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Form Approved: OMB No. 0910-0120 Expiration Date: 08/30/2023 See PRA Statement below.

#### Indications for Use

510(k) Number (if known) K212149

Device Name

MyndMove 2.0

Indications for Use (Describe)

MYNDMOVE is an electrical stimulation device indicated for the following uses:

Functional Electrical Stimulation (FES)

Improvement of ann and hand functions 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)

· Maintenance and/or increase of arm and hand range of motion

- · Prevention and/or retardation of disuse atrophy
- · Increase in local blood circulation
- · Reduction of muscle spasm

· Re-education of muscles.

Myddlove therapy can only be administered by Occupational or Physical Therapy professionals that have completed MyndMove training by Mynd Tec on the use of the MyndMove System.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (6/20)

PSC Publishing Services [phone] EF

{3}------------------------------------------------

# 510(k) Summary

# Submitter / Owner Information

MyndTec Inc. 1900 Minnesota Court, Suite 122 Mississauga, Ontario Canada, L5N 3C9

## Contact Person

Yesmil Pena Telephone:: [phone] ext. 225 Toll Free: 1-888-363-0581 Fax: [phone] [e-mail]

#### Date Prepared:

March 02, 2022

## Device Identification

| A. Name of Device | MyndMove System and MyndMove Functional<br>Electrical Stimulator |
|--------------------------|-------------------------------------------------------------------------------------------------------|
| B. Classification Name | External Functional Neuromuscular Stimulator and<br>Powered Muscle Stimulator |
| C. Proprietary Name | MyndMove 2.0 |
| D. Device Classification | Class II |
| E. Panel | Neurology |
| F. Device Product Code | GZI and IPF |
| G. Regulation Number | 882.5810 External functional neuromuscular<br>stimulators, and<br>890.5850 Powered Muscle stimulators |
| H. Previous FDA Status | no prior FDA Status |
| I. Basis for Submission | Modified Device |

#### Identification of Predicate Device

| Device | Applicant | 510(k) No. | Date Cleared |
|----------|--------------|------------|-----------------|
| MyndMove | MyndTec Inc. | K170564 | August 30, 2017 |

## Device Description

The purpose of this Traditional 510(k) is to obtain clearance for MyndMove 2.0, a modified version of the MyndMove device (K170564) functional electrical and neuromuscular

{4}------------------------------------------------

stimulation device. The MyndMove device (K170564) has undergone minor modifications resulting in the MyndMove 2.0 version. The modifications are a change of the stimulator tablet material due to availability, the removal of the internal battery from the design of the MyndMove 2.0, the addition of IP22 rated ingress protection and the addition of an optional cart to facilitate mobility in the clinical environment. A slight change in the final paragraph after the indications for use to add Physiotherapist Assistants (PTAs) and Occupational Therapy Assistants (OTAs) in addition to Physiotherapists (PTs) and Occupational Therapists (OTs) as authorized users of the MyndMove 2.0 upon training and licensing by State Law, in alignment with Medicare and TRICARE policies.

The MyndMove 2.0 System is a neuromodulation device that delivers short electrical pulses to stimulate muscle contractions and enhance motor recovery following Stroke or Spinal Cord Injury. The MyndMove system comprises the Stimulator device, stimulation electrodes and cables, hand and foot switches, and integrated software. The MyndMove 2.0 Functional Electrical Stimulator is an eight-channel device 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 Stimulator is connected, via an IEEE 802.11 a/b/q/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 ecosystem including but not limited to patient unique IDs and prescriptions, therapist profiles and stimulation protocols. MyndMove 2.0 Therapy 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 system.

MyndMove 2.0 uses 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 2.0 is 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 2.0 protocols achieve a wide range of reaching and grasping functions. During the delivery of MyndMove 2.0 therapy, the patient executes functional tasks with assistance from the therapist and the 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 move and as the arm and/or hand is moved into the instructed position. 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 2.0 is an electrical stimulation device indicated for the following uses:

## Functional Electrical Stimulation (FES)

{5}------------------------------------------------

Improvement of arm and hand functions and active range of motion in patients with hemiplegia due to stroke or upperlimb paralysis due to C3-T1 spinal cord injury.

#### NeuroMuscular Electrical Stimulation (NMES)

- . Maintenance and/or increase of arm and hand range of motion
- Prevention and/or retardation of disuse atrophy
- . Increase in local blood circulation
- . Reduction of muscle spasm
- . Re-education of muscles.

MyndMove therapy can only be administered by Occupational or Physical Therapy professionals that have completed MyndMove training by MyndTec on the use of the MyndMove System.

# Type of Use

Prescription Use (Rx)

## Performance Standards

MyndMove 2.0 complies with the current medical electrical equipment electromagnetic compatibility basic safety and performance, and software standards listed below, as verified upon Third Party testing for compliance with 60601-2-10 Edition 2.1 2016-04, ( basic safety and essential performance of nerve and muscle stimulators), ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (basic safety and essential performance); 60601-1-2 Edition 4.0 2014-02 ( basic safety and essential performance for Electromagnetic disturbances); 60601-1-11 Edition 2.0 2015-01( basic safety and essential performance requirements for medical electrical equipment a used in the home healthcare environment). MyndMove also complies with IEC 62304:2006 Medical device software - Software life cycle processes and 60601-1-6:2010 Third Edition + A1:2013 (basic safety and essential performance for usability). No additional usability testing to the original cleared device was required. There was no change to the hardware or

software design. Performance testing was performed also internally against the same specifications of the cleared device.

As part of performance testing, six oscilloscope tracings were generated for 500 ohm, 2k ohm and 10k ohms and include output mode, amplitude baseline, load resistance, pulse width, and electrode surface area with the corresponding maximum power density and average current density per surface area. The maximum net charge per pulse and phase charge for the modified device MyndMove 2.0 are identical to those of the cleared device MyndMove. The net charge per pulse for both the modified and cleared devices is 1.85 µC, and the maximum phase charge is 9.02 uC.

| 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). |

{6}------------------------------------------------

| 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 electrica<br>systems used in the home healthcare environment. |

# Basis for Substantial Equivalence

MyndTec Inc.'s MyndMove and MyndMove 2.0 are similar in design, function and technical specifications. Both devices have the same intended use and deliver functional electrical and neuromuscular stimulation using coded therapeutic algorithmic protocols using an eightchannel stimulator with a maximum 20 mA output current for all 9cm x 5cm, 5cm, 2.5cm diameter and 1cm x 3cm sinqle use electrodes. Both the cleared and modified device have almost identical technical specifications as illustrated in the table below.

MyndMove 2.0 is the result of the removal of the battery, an upgrade of the tablet PC and other modifications to meet home use requirements, maximum current equal to all electrodes, the addition of scapula protocols, and the addition of an optional cart. The predicate device MyndMove has maximum outputs for electrodes depending on size, ranging from 5mA for a 3cm2 electrode, the smallest size, to 20mA for a 45cm2 electrode, the largest size. The modified MyndMove 2.0 applies a maximum 20 mA output current for all electrodes regardless of electrode size to enable the therapist to select the peak currents to generate full muscle recruitment with any electrode size, particularly with denervated muscles. In both the predicate and modified devices, peak current values for all electrode sizes fall under the 2mA/cm maximum allowed by IEC 60601-2-10. Scapula protocols were added to the existing deltoid anatomical sites to optimize patient objectives. An analysis of the performance testing results and all similarities and differences listed in the table below

leads to determine that the modified MyndMove 2.0 has the same technical characteristics the cleared MyndMove. The differences do not raise any concerns regarding safety and effectiveness. Therefore, MyndMove 2.0 is substantially equivalent to the predicate device, the cleared MyndMove.

| Substantial Equivalence discussion for subject device MyndMove 2.0 and predicate device MyndMove. | | | |
|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Cleared Device MyndMove | Modified Device MyndMove 2.0 | SE Comparison |
| 510(k) Number | K170564 | (To Be Assigned) | |
| Indications for Use | MyndMove is an electrical stimulation device<br>indicated for the following uses: | MyndMove is an electrical stimulation device<br>indicated for the following uses: | Identical |
| | Functional electrical stimulation (FES) | Functional electrical stimulation (FES) | |
| | Improvement of arm and hand function and<br>active range of motion in patients with hemiplegia<br>due to stroke or upper limb paralysis due to<br>C3-T1 spinal cord injury.<br>NeuroMuscular Electrical Stimulation (NMES)<br>• maintenance and/or increase of arm and hand<br>range of motion,<br>• prevention and/or retardation of 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 administered by<br>Occupational or Physical Therapists that have<br>completed MyndMove training by MyndTec on the<br>use of the MyndMove System. | Improvement of arm and hand function and<br>active range of motion in patients with hemiplegia<br>due to stroke or upper limb paralysis due to<br>C3-T1 spinal cord injury.<br>NeuroMuscular Electrical Stimulation (NMES)<br>• maintenance and/or increase of arm and hand<br>range of motion,<br>• prevention and/or retardation of 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 administered by<br>Occupational or Physical Therapy<br>professionals that have completed MyndMove<br>training by MyndTec on the use of the<br>MyndMove System. | (There was a minor<br>change on the last<br>statement from<br>'Occupational or<br>Physical Therapists' to<br>'Occupational or<br>Physical Therapy<br>professionals' to<br>enable Occupational<br>or Physical Therapy<br>Assistants (OTAs or<br>PTAs) to administer<br>the MyndMove<br>therapy with the<br>appropriate training<br>and per the<br>corresponding<br>jurisdiction laws and<br>regulations).This<br>change does not alter<br>the intended use. |
| Anatomical Sites<br>for Stimulation<br>(Upper Limb) | The MyndMove System stimulates the<br>following Muscles:<br>Extensor Digitorum, Extensor Carpi Radialis<br>& Extensor Carpi Ulnaris<br>Thenar Eminence (Opponens Pollicis Brevis,<br>Flexor Pollicis Brevis & Abductor Pollicis<br>Brevis)<br>Flexor Digitorum Superficialis and Flexor | The MyndMove System stimulates the<br>following Muscles:<br>Extensor Digitorum, Extensor Carpi Radialis<br>& Extensor Carpi Ulnaris<br>Thenar Eminence (Opponens Pollicis Brevis,<br>Flexor Pollicis Brevis & Abductor Pollicis<br>Brevis)<br>Flexor Digitorum Superficialis and Flexor | Equivalent<br>Please refer to the<br>Scapula protocol<br>addition discussion |
| | 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 | 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, Upper<br>Trapezius (Scapula). | below. |
| | | Serratus Anterior, Lower Trapezius, Upper<br>Trapezius (Scapula). | |
| Where Used | Used for therapy sessions in a clinical setting<br>only. | Used for therapy sessions in a clinical setting<br>and for home use by a qualified user. | Equivalent<br>MyndMove 2.0 was<br>designed for and<br>tested against<br>60601-<br>1-11 (home<br>healthcare) |
| Regulated current<br>or | Current Regulated | Current Regulated | Identical |
| regulated voltage?<br>Software/<br>firmware/<br>microprocessor<br>control? (yes/no) | Yes | Yes | Identical |
| Automatic<br>overload trip?<br>(yes/no) | Yes | Yes | Identical |
| Automatic no- load<br>trip? (yes/no) | Yes | Yes | Identical |
| Automatic shut<br>off? (yes/no) | Yes | Yes | Identical |
| User override<br>control? (yes/no) | Yes | Yes | Identical |
| Indicator display: | Yes | Yes | Identical |
| - On/off status?<br>(yes/no) | Yes | Yes | Identical |
| - Low battery?<br>(yes/no) | Yes | Yes | Identical |
| - Voltage/current<br>level? (yes/no) | Yes | Yes | Identical |
| Timer range<br>( minutes ) | Stimulation time controlled by user. | Stimulation time controlled by user. | Identical |
| | Max duration of stimulation program = 120<br>minutes (configurable in the backend) | Max duration of stimulation program = 120<br>minutes (configurable in the backend) | |
| Compliance with<br>voluntary<br>standards? (if yes,<br>specify) | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10 | ANSI AAMI ES 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10 | Equivalent |
| Compliance with<br>21 CFR 898?<br>(yes/no) | Yes | Yes | Identical |
| Power Sources | Mains OR Rechargeable Li-Ion Battery.<br><br>Rechargeable Li-Ion:<br>14.8 V DC, 2000 mAh<br><br>Power Supply Input: 100-240 V AC, 1.2A, 50-<br>60 Hz<br>Power Supply Output: 24 V DC, 4.16 A, 100W | AHM100PS24C2-8 manufactured by XP-Power<br>100-240 V AC, 1.2 A, 50-60 Hz<br>24 V DC, 4.16 A, 100 W<br>Tripp Lite P012-006, 1-15P to C7 -10A, 120V, 18<br>AWG, 6 ft., Black<br>Sabic, Lexan Polycarbonate<br>: Sabic, Lexan Polycarbonate<br>Sabic, Lexan Polycarbonate Covestro, Makrolon<br>2805 Polycarbonate TPE E4001-40-J02 | Equivalent |
| Method of line<br>current isolation | Galvanic Isolation (transformer) 4000 VAC | Galvanic Isolation (transformer) 4000 VAC | Identical |
| Normal<br>condition (uA) | Earth Leakage: < 500 uA<br>Lead to Ground: < 100 uA | Earth Leakage: < 500 uA<br>Lead to Ground: < 100 uA | Identical |
| Single<br>fault condition<br>(uA) | Earth Leakage: < 1000 uA<br>Lead to Ground: < 500 uA<br>Patient on Mains: < 5000 uA | Earth Leakage: < 1000 uA<br>Lead to Ground: < 500 uA<br>Patient on Mains: < 5000 uA | Identical |
| Average DC<br>current through<br>electrodes when<br>device is on but<br>no pulses are<br>being applied (uA) | Patient auxiliary current: Normal condition: < 100<br>uA<br>Single fault condition: < 500 uA | Patient auxiliary current: Normal condition: < 100<br>uA<br>Single fault condition: < 500 uA | Identical |
| Number of output<br>modes (ie.<br>Number of<br>stimulation<br>protocols) | Two Modes (applicable to all 33 stimulation<br>protocols):<br>- Biphasic Symmetric<br>- Biphasic Asymmetric | Biphasic Asymmetric | Similar |
| Number of output<br>channels | 8 | 8 | Identical |
| Synchronous or<br>Alternating? | Asynchronous (channels are staggered) | Asynchronous (channels are staggered) | Identical |
| Method of channel<br>isolation | Galvanic isolation (transformer): 1500VAC/3kV DC…