Nerve and Muscle Stimulator (Model: XFT-2001EA) is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of walking, the Nerve and Muscle Stimulator (Model: XFT-2001EA) electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the individual's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased local blood flow, muscle reeducation, and maintained or increased joint range of motion.

Device Description

Nerve and Muscle Stimulator (Model: XFT-2001EA) is a wearable and DC 3.7V rechargeable lithium battery powered multifunction device, and integrated metal (stainless-steel) electrodes, offering Functional Electrical Stimulation (FES) in device. It can be attached to the leg just below the knee, near the head of the fibula. During a gait cycle, the Nerve and Muscle Stimulates the common peroneal nerve via metal electrode, which innervates the tibialis anterior and other muscles that cause dorsiflexion of the ankle.

The Nerve and Muscle Stimulator is a microprocessor-controlled device, and uses a smart phone operating application (APP) to store device, user and configuration information via Bluetooth. it can be operated by both smart phone application and the control panel of the device.

Nerve and Muscle Stimulator has 3 working mode, Walk Mode, Training Mode and Evaluation Mode. The walk mode and training mode which can give certain electrical pulses through metal electrode to the proposed area of the leg where the Nerve and Muscle Stimulator are placed. There is no electrical stimulation in the evaluation mode, it is intended to collect the tilt angle data generated by the Stimulator during the patient's walking, and can calculate the recommend parameters based on the collected data.

The control panel of the device has the operating elements of ON/OFF touch button, OLED display, mode selection touch button, intensity touch button and USB port for battery charging. The OLED display can show battery power, selected mode, current intensity and indication of a pause.

The stimulator will connect the APP via Bluetooth, user can set the parameters, mode selection, and intensity adjustment of the stimulation by APP. Logout of the APP or disconnect the Bluetooth, the stimulator can continue to work.

AI/ML Overview

This FDA 510(k) summary is for a medical device (Nerve and Muscle Stimulator, Model: XFT-2001EA) seeking clearance based on substantial equivalence to a predicate device (XFT-2001D). The document primarily focuses on demonstrating that the new device is as safe and effective as the predicate, rather than providing a detailed study proving it meets specific clinical or diagnostic acceptance criteria for a novel functionality.

Given the nature of a 510(k) submission for substantial equivalence where clinical data is often not required for device performance, the document relies heavily on comparison to a predicate device and compliance with established electrical, biocompatibility, and performance standards. It does not contain information typically found in a clinical study report that would establish specific acceptance criteria for diagnostic performance or treatment efficacy.

Therefore, many of the requested sections (e.g., sample size for test set, data provenance, ground truth establishment for test/training sets, adjudication methods, MRMC studies, standalone performance) are not present in this type of regulatory submission. The document focuses on bench testing and comparisons to established safety and performance parameters rather than human-centric performance metrics.

However, I can extract the relevant information regarding acceptance criteria and the "study" (which in this context refers to non-clinical testing performed for regulatory clearance) that demonstrates the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in numerical thresholds within the document, but are implicitly defined by compliance with specified international and national standards, and by showing equivalence or acceptable differences compared to the predicate device. The "reported device performance" is largely demonstrated through successful completion of these compliance tests.

Acceptance Criterion (Implicit)	Reported Device Performance (Demonstrated by)
Electrical Safety and Essential Performance (IEC 60601-1)	Device passed safety testing according to ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) (IEC 60601-1:2005, MOD).
Electromagnetic Compatibility (IEC 60601-1-2)	Device passed IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.
Home Healthcare Environment Compliance (IEC 60601-1-11)	Device passed IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
Nerve and Muscle Stimulator Specific Safety (IEC 60601-2-10)	Device passed IEC 60601-2-10:2012+AM1:2016 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
Wireless Coexistence (ANSI/IEEE C63.27, FCC Part 15 Subpart C & B)	Device passed ANSI/IEEE C63.27:2017 American National Standard for Evaluation of Wireless Coexistence and FCC Rules and Regulations, Part 15, Subpart C and Subpart B. Wireless control noted as "meeting requirements of wireless coexistence," ensuring "quality of wireless could be assured during normal use."
Rechargeable Battery Safety (IEC 62133-2)	Rechargeable lithium battery passed IEC 62133-2:2017.
Biocompatibility (ISO 10993-5, ISO 10993-10)	Device passed biocompatibility tests according to ISO 10993-5:2009 (Tests for in vitro cytotoxicity) and ISO 10993-10:2010 (Tests for irritation and skin sensitization). Differences in electrode and cuff materials from the predicate were addressed by these tests.
Performance Testing (FDA Guidance for Powered Muscle Stimulators)	Device conducted and passed performance testing according to FDA guidance "Guidance Document for Powered Muscle Stimulator 510(k)s, document issued on June 9, 1999." Although specific numerical output parameters (Max Output Current, Frequency, Max Current Density, Max Average Current, Max Average Power Density) differed from the predicate, they were found to be "within the acceptable range by comparison with the device which previously cleared" and "do not impact safety and effectiveness."
Substantial Equivalence to Predicate	The device is concluded to be substantially equivalent to the predicate device (K162718) based on intended use, technological characteristics, output mode, and applicable safety standards. Differences (power source capacity, number of output modes, specific electrical output parameters, electrode size/shape/materials, cuff materials, wireless control mechanism, weight, dimensions) were individually evaluated and found not to "raise any new issues or concerns of safety or effectiveness" because they either complied with standards, were within acceptable ranges of previously cleared devices, or were demonstrated safe/effective through specific non-clinical tests (e.g., biocompatibility, wireless coexistence).

Detailed Breakdown of Requested Information (based on the provided document):

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: As detailed in the table above, the acceptance criteria are largely defined by compliance with specific international and national standards (e.g., IEC 60601 series, ISO 10993 series, ANSI/IEEE C63.27, FCC regulations) and by the demonstration that any differences from the predicate device do not raise new safety or effectiveness concerns.
- Reported Device Performance: The reported performance is the successful passing of all listed non-clinical tests based on these standards and the justification for differences from the predicate.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This document describes non-clinical bench testing. It does not involve a "test set" in the context of patient data. Therefore, sample size, data provenance, and retrospective/prospective nature are not applicable or detailed for human-subject data. The "test sets" would refer to the specific units of the device models (XFT-2001E, XFT-2001EA) used for the various bench tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This is a 510(k) submission for a non-diagnostic, therapeutic device, and the clearance is based on non-clinical testing and substantial equivalence, not on expert-adjudicated performance against a "ground truth" derived from patient data. The "ground truth" here is compliance with engineering and biocompatibility standards, assessed by testing laboratories.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no human-reader adjudication for performance of this device in this submission.
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. This device is a nerve and muscle stimulator, not an AI-powered diagnostic tool. No MRMC study was performed or mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "standalone performance" in this context refers to the device itself meeting the performance and safety standards through bench testing. The document states that the proposed device "passed safety testing" and "passed biocompatibility tests" and "conducted and passed performance testing-bench." This directly addresses the standalone performance of the physical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this regulatory submission is compliance with established international and national medical device safety and performance standards (e.g., IEC 60601 series, ISO 10993 series, FCC regulations) and FDA guidance for similar devices. It is based on objective, quantifiable measurements performed during bench testing by accredited laboratories and assessed against the requirements of these standards.
The sample size for the training set:
- Not applicable. This device is not an AI/machine learning device that requires a training set in the conventional sense.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/machine learning algorithm described in this submission.

Summary

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September 23, 2020

Shenzhen XFT Medical Limited % Yovo Chen Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town Shenzhen, 518100 Cn

Re: K193276

Trade/Device Name: Nerve and Muscle Stimulator Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI Dated: September 3, 2020 Received: September 9, 2020

Dear Yoyo Chen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Vivek Pinto, PhD 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

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Indications for Use

510(k) Number (if known)

Device Name Nerve and Muscle Stimulator

Indications for Use (Describe)

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

This summary of 510(K) safety and effectiveness information is submitted As Required by requirements of SMDA and 21 CFR §807.92.

1. Administrative Information

Submission Date	September 3 ,2020
Manufacturerinformation	Submitter's Name: Shenzhen XFT Medical LimitedAddress: Room 203, Building 1, Biomedicine InnovationsIndustrial Park #14 Jinhui Road, Pingshan New DistrictShenzhen Guangdong, CHINA 518118Contact person: Ms. Julia YeTEL:+86(0755) 29888818FAX: +86(0755) 28312625E-Mail: xftrs2@xft.cn; xfthr1@xft.cn;
SubmissionCorrespondent	Shenzhen Joyantech Consulting Co., Ltd.1713A, 17th Floor, Block A, Zhongguan Times Square, LiuxianAvenue, Xili Town, Nanshan District, Shenzhen, GuangdongProvince, China.Contact person: Ms. Yoyo Chen, Mr. Field FuE-Mail: yoyo@cefda.com; field@cefda.comImage: [logo]
Establishmentregistration number	3004438577

2. Device Information

Type of 510(k) Submission:	Traditional
Common name of the device:	Nerve and Muscle Stimulator
Trade name of the device:	Foot Drop System
Type/Model of the device:	XFT-2001E and XFT-2001EA
Classification name:	Stimulator, Neuromuscular, External Functional;
Review Panel:	Neurology
Device Class	II
Regulation Number	21 CFR 882.5810

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3. Predicate Device

Manufacturer	Shenzhen XFT Medical Limited
Trade name	Foot Drop System
Model	XFT-2001D
510(K) Number:	K162718
Product Code	GZI

4. Device Description

5. Intended Use/Indication for Use

Nerve and Muscle Stimulator (Model: XFT-2001E, XFT-2001EA) is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of walking, the Nerve and Muscle

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Stimulator (Model: XFT-2001E, XFT-2001EA) electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the individual's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased local blood flow, muscle reeducation, and maintained or increased joint range of motion.

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6. Comparison with predicate device

The Nerve and Muscle Stimulator (Model, XFT-2001EA) is substantially equivalent to the predicate device (K162718). This conclusion is based upon comparison on intended use, technological characteristics, output mode and standards. Any difference in the technological characteristics does not raise any new issues or concerns of safety or effectiveness.

Items	New Device(K193726)XFT-2001E and XFT-2001EA	Predicate Device(K162718)XFT-2001D	Comparison
Product code	GZI	GZI	Same
Regulation number	21 CFR 882.5810	21 CFR 882.5810	Same
Device class	2	2	Same
Manufacturer	Shenzhen XFT Medical Limited	Shenzhen XFT Medical Limited	Same
Intended use	Nerve and Muscle Stimulator (Model: XFT-2001E, XFT-2001EA) is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of walking, the Nerve and Muscle Stimulator (Model: XFT-2001E, XFT-2001EA) electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the individual's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased local blood flow, muscle reeducation,	XFT-2001D Foot Drop System is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of walking, the XFT-2001D, electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the individual's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased local blood flow, muscle reeducation, and maintained or increased joint range of motion.	Same
Items	New Device(K193726)XFT-2001E and XFT-2001EAand maintained or increased joint range ofmotion.	Predicate Device(K162718)XFT-2001D	Comparison
Patient Population	Adult	Adult	Same
Power source	DC 3.7V, 450mAh, rechargeable lithium battery	DC 3.7V, 400mAh, rechargeable lithium battery	Different(Note1)
-Method of Line Current Isolation	Type BF	Type BF	Same
-Patient Leakage Current (mA):-Normal condition	Normal condition: 0.5mA	Normal condition: 0.5mA	Same
- Single fault condition	Single fault condition: 2mA	Single fault condition: 2mA
Number of Output Modes	3 modes:Walk Mode, Training Mode and Evaluation Mode:• There are 2 modes under walk mode- Smart mode and Normal mode;• There are 10 modes under training mode- 9 preset modes and 1 customize mode.	2 modes:Gait Mode and Training Mode:• There are 3 modes under gait mode-Smart mode, Normal mode and Gait Analysis;• There are 10 modes under training mode- 9 preset modes and 1 customized mode.	Different(Note2)
Number of Output Channels	1	1	Same
Waveform	Asymmetrical Biphasic	Asymmetrical Biphasic	Same
Shape	Rectangular	Rectangular	Same
Maximum Output Voltage (volts) (+/-10%)	45V@500 Ω90V@1KΩ156V@2K Ω158V@10K Ω	45V@500 Ω90V@1KΩ156V@2K Ω158V@10K Ω	Same
Items	New Device(K193726)XFT-2001E and XFT-2001EA	Predicate Device(K162718)XFT-2001D	Comparison
Maximum Output Current (mA) (+/-10%)	15.58mA rms @500 Ω13.51mA rms @ 2 kΩ2.73mA rms @ 10 kΩ	14mA rms @500 Ω11mA rms @ 2 kΩ2.2mA rms @ 10 kΩ	Different(Note3)
Duration of primary (depolarizing)phase (µ sec)	Unknown	Unknown	Same
Pulse Duration (µ sec) (+/- 10%)	100~300 µ secPulse width adjustable in following discretesteps:100/150/200/250/300 µ sec	100~300 µ secPulse width adjustable in following discretesteps:100/150/200/250/300 µ sec	Same
Frequency (Hz) (+/- 10%)	16~50 HzFrequency adjustable in following discrete steps:16/ 20/ 25/ 33/ 40 / 50Hz	16~33HzFrequency adjustable in following discrete steps:16/ 20/ 25/ 33Hz	Different(Note3)
For interferential modes only:-Beat Frequency (Hz)	Unknown	Unknown	Same
For multiphasic waveforms only:-Symmetrical phases?-Phase Duration (include units)(state range, if applicable)(both phases, if asymmetrical)	No symmetrical phase	No symmetrical phase	Same
Net Charge (microcoulombs (µC) perpulse)	0µC@500 Ω	0µC@500 Ω	Same
Maximum Phase Charge, (µC) ±10%	27µC @500Ω23.4µC @2kΩ4.74μC @10kΩ	27µC @500Ω23.4µC @2kΩ4.74μC @10kΩ	Same

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Items	New Device(K193726)XFT-2001E and XFT-2001EA	Predicate Device(K162718)XFT-2001D	Comparison
Maximum Current Density (mA/cm², r.m.s.) ±10%	0.53mA/cm² @500Ω0.46mA/cm² @2kΩ0.09mA/cm² @10kΩ	0.7mA/cm² @500Ω0.58mA/cm² @2kΩ0.11mA/cm² @10kΩ	Different(Note3)
Maximum Average Current (average absolute value), mA±10%	15.58mA @500Ω13.51mA @2kΩ2.73mA @10kΩ	12.66mA @500Ω10.97mA @2kΩ2.22mA @10kΩ	Different(Note3)
Maximum Average Power Density, (W/cm²)	0.008W/cm² @500Ω0.025 W/cm² @2KΩ0.005 W/cm² @10KΩ	0.005W/cm²@500 Ω0.014W/cm²@2KΩ0.003W/cm²@2KΩ	Different(Note3)
BurstMode	(a) Pulses per burst	Burst length and PPS dependent	Burst length and PPS dependent	Same
	(b) Bursts per second	Depends on duration times and interval times	Depends on duration times and interval times	Same
	(c) Burst duration (seconds)	1 to 5 sec in 0.1 sec steps Depends on duration times and interval times	1 to 5 sec in 0.1 sec steps Depends on duration times and interval times
	(d) Duty Cycle: Line (b) x Line (c)	unknow	unknow
IndicatorDisplay		On/Off Status?Low Battery?Voltage/Current Level?	YesYesYes		YesYesYes
		Duration Time /ON time (Seconds)	1-5 sec in 0.1 sec steps		1-5 sec in 0.1 sec steps
		Interval Time /OFF time (Seconds)	1-10 sec in 0.1 sec steps	1-10 sec in 0.1 sec steps	Same
Timer Range (Minutes)		20 minutes		20 minutes	Same
Stimulation Trigger Source		Tilt sensor		Tilt sensor	Same

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Items	New Device(K193726)XFT-2001E and XFT-2001EA	Predicate Device(K162718)XFT-2001D	Comparison
Anatomical Sites	Limb	Limb	Same
Shipping and Storage	Temp:-20°C to 55°CRelative Humidity ≤93%Atmos: 70-106KPa	Temp:-20°C to 55°CRelative Humidity ≤93%Atmos: 70-106KPa	Same
Operating Conditions	Temp:5°C to 40°CRelative Humidity ≤80%Atmos: 86-106KPa	Temp:5°C to 40°CRelative Humidity ≤80%Atmos: 86-106KPa	Same
Electrode Size and Shape	Rectangular 1(29.3218.04mm),Rectangular 2(28.2618.38mm),Rectangular 3(29.0117.89mm),Rectangular 4(89.0032.80mm)	5 cm diameter Round	Different(Note4)
Electrode materials	Stainless steel SUS 316L	Hydrogel/conductive fabrics	Different(Note4)
Materials-Cuff	TPE (Thermoplastic Elastomer)	Fabric	Different(Note5)
Maximum Stimulation Period	5 seconds	5 seconds	Same
Wireless Communication	Blue tooth 4.0	Blue tooth 4.0	Same
Wireless Control	Smart phone application	Remote control	Different(Note 6)
Weight	XFT-2001E:155g;XFT-2001EA: 140g	43g	Different(Note7)
Dimensions (mm) [W x H x D]	XFT-2001E: 126.8 x102.4 x15.5mm;XFT-2001EA: 122.8 x104.8 x15.9mm	737010mm	Different(Note7)
Items	New Device(K193726)XFT-2001E and XFT-2001EA	Predicate Device(K162718)XFT-2001D	Comparison
Housing Materials and Construction	ABS	ABS	Same
Expected Service Life	5 years	5 years	Same
Compliance with 21 CFR 898?	Yes	Yes	Same
Compliance with Voluntary Standards	IEC 60601-1IEC 60601-1-2IEC 60601-2-10	IEC 60601-1IEC 60601-1-2IEC 60601-2-10	Same

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Note1: Power source

The difference between the subject device and predicate device for power source is the capacity of rechargeable lithium battery. However, the battery is complied with IEC 62133-2:2017 standard requirements, and the subject devices have passed the IEC 60601-1 test standard. Therefore, the difference between the subject and predicate devices do not impact safety and effectiveness.

Note 2: Number of Output Modes

Based on the performance testing in comparison with the predicate device under different loads, it is concluded that the difference does not raise any safety or effectiveness issues.

Note 3: Maximum Output Current, Frequency, Maximum Current Density, Maximum Average Current, Maximum Average Power Density

Although the above parameters of subject device are different with the predicate device, but these parameters are within the acceptable range by comparison with the device which previously cleared. Therefore, the difference between the subject and predicate devices do not impact safety and effectiveness.

Note 4: Electrode Size, Shape and Electrode materials

Although the electrode is different with predicate device, however, the tests for biocompatibility, durability and electrical safety test are all carried out to ensure the device could be safe and effective during normal use. Therefore, it is considered that the difference between the subject and predicate devices does not impact safety and effectiveness.

Note 5: Materials-Cuff

Even though the electrode and cuff material of subject devices are is different with Predicate Device, but they all passes biocompatibility test in according to ISO 10993-5 and ISO 10993-10 standards. Therefore, these differences do not impact safety and effectiveness.

Note 6: Wireless Control

Although the wireless control of subject device is different with predicate device, but they all meet the requirements of wireless coexistence. Based on the performance test result of wireless coexistence, the quality of wireless could be assured during normal use. Therefore, the difference does not raise any safety or effectiveness issues.

Note 7: Weight and Dimensions

After comparison with the previously declared device, we believe that the weight of subject device could be safe and effective during normal use for this type of device. Regarding the dimension of subject device, it could be adjusted during normal use to accommodate the leg circumferences of intended population, and ensure the device could be fit during normal use. Therefore, the difference does not raise any safety or effectiveness issues.

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Non-Clinical Test Summary 7.

7.1. Electromagnetic Compatibility and Electrical Safety Test

The proposed device Nerve and Muscle Stimulator (Model: XFT-2001E, XFT-2001EA) has passed safety testing in according to following standards.

1. ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD).
IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for 2) basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
1. IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
1. IEC 60601-2-10:2012+AM1:2016 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
1. ANSI/IEEE C63.27:2017 American National Standard for Evaluation of Wireless Coexistence
FCC Rules and Regulations, Part 15, Subpart C and Subpart B 6)

The rechargeable lithium battery has passed the IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.

The power adapter has passed the ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-11:2005, MOD).

7.2. Biocompatibility Test

The proposed device Nerve and Muscle Stimulator (Model: XFT-2001E, XFT-2001EA) has passed biocompatibility tests in according to following standards:

1. ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation 2) and skin sensitization

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7.3. Performance Testing-Bench

The proposed device Nerve and Muscle Stimulator (Model: XFT-2001E, XFT-2001EA) has conducted and passed performance testing in according to FDA guidance-Guidance for Industry, FDA Reviewer/Staff and Compliance-Guidance Document for Powered Muscle Stimulator 510(k)s, document issued on June 9, 1999.

8. Clinical Test Data

Substantial equivalence does not depend on the clinical test data.

9. Conclusion

The Nerve and Muscle Stimulator (Model: XFT-2001E, XFT-2001EA) is substantially equivalent to the predicate device (K162718). This conclusion is based upon comparison on intended use, technological characteristics, output mode and applicable safety standards. Any difference in the technological characteristics does not raise any new issues or concerns of safety or effectiveness.

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).