Relaxation of muscle spasms;
Prevention or retardation of disuse atrophy;
Increasing local blood circulation;
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis;
Maintaining or increasing range of motion;
Stroke Rehab by Muscle re-education.

Device Description

The Nerve and Muscle Stimulator (model: XFT-2003K) is an electrical muscle stimulator for contraction of muscles as indicated above. The Nerve and Muscle Stimulator (model: XFT-2003K) is also an electromyography device. It is intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves and to monitor and display the electrical activity produced by nerves. The indications for use are muscle reeducation, relaxation and biofeedback.

Nerve and Muscle Stimulator (model: XFT-2003K) is powered by MAINS SUPPLY AC 100-240V, 50-60Hz, and used together with Electrode cup (including Sponge).

The device is used for prescription. It is neither for life-supporting nor for implanting. It does not contain any drug or biological product and it does not need to be sterilized.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Nerve and Muscle Stimulator:

The provided document is a 510(k) Summary for a medical device (Nerve and Muscle Stimulator, model XFT-2003k) seeking substantial equivalence to a predicate device (MYOTRAC INFINITI, K053266). This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed device, rather than proving its absolute safety and effectiveness through extensive new clinical trials.

Therefore, direct acceptance criteria and a "study that proves the device meets the acceptance criteria" in the traditional sense of a de novo device approval are not present in this document. Instead, the document provides a comparison to a predicate device and relies on adherence to recognized standards and the established safety and effectiveness of the predicate.

Here's a breakdown of the requested information based on the provided text, with explanations where direct answers are not available:

1. Table of acceptance criteria and the reported device performance

As mentioned, there are no explicit "acceptance criteria" presented as specific performance metrics and thresholds for the subject device to meet independently. The core of this 510(k) submission is to demonstrate substantial equivalence to the predicate device. The "performance" reported is primarily in terms of compliance with recognized electrical safety, EMC, and biocompatibility standards, and a detailed parameter-by-parameter comparison with the predicate device.

Here's a table summarizing the reported device performance in relation to the predicate, as presented in the "SE Comprehensive Comparison Table" and "SE General Specification Comparison Table":

Acceptance Criteria (Implied by Predicate Comparison & Standards)	Reported Subject Device Performance
Intended Use/Indications for Use: Equivalent to predicate.	sEMG: Biofeedback, Relaxation & Muscle Re-Education purposes.
	NMES (muscle stimulation) and sEMG triggered stimulation (Including ETS, PAS and MIRROR Mode): 1) Relaxation of muscle spasms; 2) Prevention or retardation of disuse atrophy; 3) Increasing local blood circulation; 4) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; 5) Maintaining or increasing range of motion; 6) Stroke Rehab by Muscle re-education. (Stated as "SE" (substantially equivalent) to predicate, which has largely similar indications with 7 points.)
Biocompatibility: Compliance with ISO 10993-1/-5/-10.	Compliance with ISO 10993-1/-5/-10: All patient contacting materials are in compliance. ("Same" as predicate.)
Electrical Safety: Compliance with IEC 60601-1.	Compliance with IEC 60601-1: Demonstrated. ("Same" as predicate.)
EMC: Compliance with IEC 60601-1-2.	Compliance with IEC 60601-1-2: Demonstrated. ("Same" as predicate.)
Performance (general): Compliance with IEC 60601-2-10.	Compliance with IEC 60601-2-10: Demonstrated. ("Same" as predicate.)
Line Current Isolation: 2MOPP.	2MOPP. ("Same" as predicate.)
Patient Leakage Current (Normal Condition): ≤ 1 μA.	≤ 1 μA. ("Same" as predicate.)
Patient Leakage Current (Single Fault Condition): ≤ 1 μA.	≤ 1 μA. ("Same" as predicate.)
Waveform: Functionally equivalent to predicate.	Pulsed, Symmetrical balanced biphasic wave (rectangular). ("SE" (substantially equivalent) to predicate's asymmetrical balanced pulsed current, indicating functional equivalence for its purpose.)
Maximum Output Voltage: Within acceptable therapeutic range.	Ranges vary by mode (e.g., NMES P1-P6: 50V@500Ω, 125V@2kΩ, 125V@10kΩ). Compared to predicate (50V@500Ω, 100V@2kΩ, 100V@10kΩ). ("SE" with remark that NMES modes are compared to STIM mode of predicate, and ETS/PAS/Mirror modes compared to Threshold/Triggered modes of predicate. Values are often the same or slightly different but within therapeutic range.)
Maximum Output Current: Within acceptable therapeutic range.	Ranges vary by mode (e.g., NMES P1-P6: 100mA@500Ω, 62.5mA@2kΩ, 12.5mA@10kΩ). Compared to predicate (100.0mA@500Ω, 50mA@2kΩ, 10mA@10kΩ). ("SE" with similar remarks as Max Output Voltage. Values are often the same or slightly different but within therapeutic range.)
Pulse Duration/width: Within acceptable therapeutic range.	Ranges vary by mode (e.g., NMES P1: 250µs; P3: 50µs; P29-P34: 400µs). Compared to predicate (50-400µs). ("SE" to predicate's range.)
Frequency: Within acceptable therapeutic range.	Ranges vary by mode (e.g., NMES P1: 5Hz; P4: 100Hz; P43: 2-250Hz). Compared to predicate (2-100Hz). ("SE" to predicate's range, with some subject device modes exceeding the predicate's upper range or having different specific frequencies.)
Net Charge per pulse: 0 (balanced).	0@500Ω. ("Same" as predicate.)
Maximum Phase Charge: Within acceptable therapeutic range.	Ranges vary by mode (e.g., NMES P1, P6: 25@500Ω; P29, P33, P37: 40@500Ω). Compared to predicate (60@500Ω). ("SE", generally lower than predicate, considered safe.)
Maximum Current Density: Equivalent or lower than predicate.	NMES: P43: 0.38977@500Ω (EC001); 0.14696@500Ω (EC002). Compared to predicate's 0.24mA/cm2 (895220) and 0.08mA/cm2 (895340). (Note 05 states treatment effect is mainly determined by Max Power Density.) The values are within the range or comparable to predicate.
Maximum Power Density: Equivalent or lower than predicate.	NMES: P30, P34, P43: 11.69@500Ω (EC001); 4.41@500Ω (EC002). Compared to predicate's 16mW/cm2 (895220) and 5.3mW/cm2 (895340). (Note 06 argues these values are "effective" by referencing other cleared devices with lower power densities, demonstrating it is within an acceptable therapeutic range.)
Burst Mode: Functionally equivalent or therapeutically acceptable.	(a) Pulses per burst: 2~6000 (Predicate: 4-2000). (Note 07 states difference does not affect safety/effectiveness because duty cycle is same.)
	(b) Bursts per second: 0.05~1 (Predicate: 0.05-0.5).
	(c) Burst duration (seconds): 1~20 (Predicate: 2-20).
	(d) Duty Cycle: 1 (Predicate: 1). ("Same" as predicate.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not applicable (N/A). The submission explicitly states "Brief discussion of clinical tests: N/A." The evaluation is based on non-clinical testing (bench testing, standards compliance) and a comparison to a predicate device, not on a clinical test set from a study.
Data provenance: N/A for clinical data. Non-clinical testing data would be generated in Shenzhen, China (manufacturer's location).

3. 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)

Number of experts and qualifications: N/A. No clinical test set with human-established ground truth was used. The ground truth for substantial equivalence is derived from the predicate device and established medical device standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication method: N/A. No clinical test set was used requiring adjudication.

5. 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

MRMC study: N/A. This is an electrical stimulator, not an imaging device with human readers or AI assistance in the way typically discussed for MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Standalone performance: The assessment for this device is essentially "standalone" in that it's the device's technical specifications and electrical outputs being compared to standards and the predicate. There isn't an "algorithm-only" component as might be found in AI/ML submissions. Its performance is evaluated on its inherent properties and safety characteristics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of ground truth: The "ground truth" in this 510(k) context is the established safety and effectiveness of the legally marketed predicate device (Thought Technology Ltd. MYOTRAC INFINITI, K053266) and adherence to recognized performance and safety standards for powered muscle stimulators (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993). The "truth" is that the predicate is safe and effective for its intended use, and the new device is substantially equivalent if it meets similar technical specifications and standards.

8. The sample size for the training set

Sample size for training set: N/A. There is no mention of a training set for an algorithm, as this device is a hardware-based electrical stimulator, not an AI/ML device.

9. How the ground truth for the training set was established

How ground truth for training set was established: N/A. No training set was used.

In summary: The provided document is a 510(k) summary, which aims to demonstrate "substantial equivalence" to a predicate device, not to prove de novo safety and effectiveness through clinical trials. Therefore, many of the questions related to clinical studies, test sets, ground truth establishment by experts, and AI performance are not applicable to this type of regulatory submission as presented. The "study" that proves the device meets the (implied) acceptance criteria is the non-clinical testing demonstrating compliance with relevant international safety and performance standards (e.g., IEC 60601 series, ISO 10993) and the detailed comparison of its technical specifications to those of a legally marketed predicate device.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 8, 2021

Shenzhen XFT Medical Limited % Field Fu Senior Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen, Guangdong China

Re: K211094

Trade/Device Name: Nerve and Muscle Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, HCC Dated: April 6, 2021 Received: April 12, 2021

Dear Field Fu:

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

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

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,

Patrick Antkowiak Acting 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}------------------------------------------------

Indications for Use

510(k) Number (if known) K211094

Device Name Nerve and Muscle Stimulator

Indications for Use (Describe)

sEMG:

Biofeedback, Relaxation & Muscle Re-Education purposes;

NMES (muscle stimulation) and sEMG triggered stimulation (IncludingETS, PAS and MIRROR Mode):

1. Relaxation of muscle spasms;

Prevention or retardation of disuse atrophy;

1. Increasing local blood circulation:
1. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis;
1. Maintaining or increasing range of motion;

Stroke Rehab by Muscle re-education.

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 PRAStaff(@fda.hhs.gov

"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."

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

Shenzhen XFT Medical Limited	510(K) Summary
Product: Nerve and Muscle Stimulator	Version: A/1

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

Date of SummarypreparedManufacturerinformation	Apr., 6, 2021Shenzhen XFT Medical Limited.Company address:Room 203, Building 1, Biomedicine InnovationsIndustrial Park, #14 Jinhui Road, Pingshan NewDistrict, Shenzhen, China.Contact person: Cindy PengPhone: +86 755 29888818Fax: +86-0755-28312625E-mail: xftrs2@xft.cn
SubmissionCorrespondentImage: logo	Shenzhen Joyantech Consulting Co., Ltd.Address: 1713A, 17th Floor, Block A,Zhongguan Times Square, Liuxian Avenue, XiliTown, Nanshan District, Shenzhen, GuangdongProvince, China.Contact person: Mr. Field FuE-Mail: field@cefda.com;
Establishmentregistration number

2 Device Information

Type of 510(k)submission:	Traditional
Trade Name:	Nerve and Muscle Stimulator
Model:	XFT-2003k
Classification name:	Stimulator, Muscle, Powered;Stimulator, Nerve,Transcutaneous, For Pain Relief.

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

Product: Nerve and Muscle Stimulator

Review Panel:	Physical Medicine; Neurology.
Product Code:	IPF; HCC.
Device Class:	II
Regulation Number:	890.5850

3 Predicate Device Information

Sponsor:	Thought Technology Ltd.
Device:	Powered muscle stimulator and biofeedback device
Device#:	SA9800
Trade name:	MYOTRAC INFINITI
510(K) Number:	K053266

4 Device Description

Nerve and Muscle Stimulator (model: XFT-2003K) is powered by MAINS SUPPLY AC 100-240V, 50-60Hz, and used together with Electrode cup (including Sponge).

The device is used for prescription. It is neither for life-supporting nor for implanting. It does not contain any drug or biological product and it does not need to be sterilized.

5 Intended Use/ Indications for Use

sEMG:

Biofeedback, Relaxation & Muscle Re-Education purposes;

NMES (muscle stimulation) and sEMG triggered stimulation (Including ETS, PAS and MIRROR Mode):

Relaxation of muscle spasms;
Prevention or retardation of disuse atrophy;

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

Shenzhen XFT Medical Limited	510(K) Summary
Product: Nerve and Muscle Stimulator	Version: A/1

Increasing local blood circulation;
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis;
Maintaining or increasing range of motion;
Stroke Rehab by Muscle re-education.

6 Technological characteristics of the subject device compared to the predicate device

Elements ofComparison	Subject Device	Predicate Device	Remarks
510(k) Number	Pending	K053266
Manufacturer	Shenzhen XFT MedicalLimited	Thought Technology Ltd.
Devicetype/model	XFT-2003K	MYOTRAC INFINITI	/
Intended use/Indicationforuse	sEMG:Biofeedback, Relaxation &Muscle Re-Educationpurposes;NMES (muscle stimulation)and sEMG triggeredstimulation (IncludingETS,PAS and MIRROR Mode):1) Relaxation of musclespasms;2) Prevention or retardation ofdisuse atrophy;3) Increasing local bloodcirculation;4) Immediate post-surgicalstimulation of calf muscles toprevent venous thrombosis;5) Maintaining or increasingrange of motion;6) Stroke Rehab by Muscle re-education.	1) Biofeedback, Relaxation andMuscle Re-Education purposes;2) Relaxation of muscle spasms;3) Prevention or retardation ofdisuse atrophy;4) Increasing local bloodcirculation;5) Immediate post-surgicalstimulation of calf muscles toprevent venous thrombosis;6) Maintaining or increasingrange of motion.7) Stroke Rehab by Muscle re-education.	SE
PrescriptionorOTC	RX	RX	SE
Electrode	EC002: 25.57cm²;EC001: 9.621cm²;	Axelgaard Model 895340:75 cm²;Axelgaard Model 895220:25cm²;	Note 01

Table 01: SE Comprehensive Comparison Table

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

510(K) Summary

Product: Nerve and Muscle Stimulator

Version: A/1

Elements ofComparison	Subject Device	Predicate Device	Remarks
Waveform	Pulsed,Symmetrical balancedbiphasic wave (rectangular)	Asymmetrical balanced pulsedcurrent	SE
Performance	Compliance with IEC 60601-2-10	Compliance with IEC 60601-2-10	Same
Biocompatibility	All the patient contactingmaterials are in compliancewith ISO 10993-1/-5/-10	All the patient contactingmaterials are in compliance withISO 10993-1/-5/-10	Same
Electrical Safety	Compliance with IEC 60601-1	Compliance with IEC 60601-1	Same
EMC	Compliance with IEC 60601-1-2	Compliance with IEC 60601-1-2	Same
ConnectingSafety	21CFR 898	21CFR 898	Same

Note 01: Maximum Current Density and Maximum Power Density are equivalent respectively.

Table 02: SE General Specification Comparison Table

Parameter	Subject Device	Predicate Device	Remarks
510(k) Number	Pending	K053266	/
Device Name andModel	XFT-2003K	MYOTRAC INFINITI	/
Manufacturer	Shenzhen XFT MedicalLimited	Thought Technology Ltd.	/
Power Source(s)	AC 110-240 50-60Hz	4 AAA batteries, single usealkaline or Rechargeablebattery pack	Note 02
---Method of Line CurrentIsolation	2MOPP	2MOPP	Same
---Patient Leakage Current:Normal Condition (μΑ)	$\u22641$	$\u22641$	Same
---Patient Leakage Current:Single Fault Condition (μΑ)	$\u22641$	$\u22641$	Same
Number of OutputModes(programs)	4	2	SE
Number of Output Channels:	Double	Double	Same
---Synchronous or Alternating?	Synchronous	Synchronous	Same
---Method of Channel Isolation	Transformer	Transformer	Same
Regulated Current or RegulatedVoltage?	Regulated Current	Regulated Voltage	SE
Software/Firmware/Microproces	Yes	Yes	Same

{7}------------------------------------------------

Product: Nerve and Muscle Stimulator

Version: A/1

Parameter	Subject Device	Predicate Device	Remarks
sor Control?
Automatic OverloadTrip?	Yes	Yes	Same
Automatic No-Load Trip?	Yes	Yes	Same
Automatic Shut Off?	Yes	No	SE
Patient Override Control?	Yes	Yes	Same
IndicatorDisplay:	On/Off Status?	yes	Yes	Same
	Low Battery?	No.	Yes	Note 03
	Voltage/CurrentLevel?	Yes	Yes	Same
Timer Range (minutes)		1-60min, step 1min	1-120min	SE
sEMG detection		Bipolar	Bipolar	same
sEMG range (μ V)		1-2000	0-5, 0-10, 5-10, 0-20, 5-20,10-20, 0-50, 10-50, 0-100,50-100,0-200, 50-200, 100-200, 0-500,100-500, 0-1000, 0-2000	SE
Feedback response frequencybands(Hz)		20-500	20-500	Same
sEMG indication accuracy		$±10%or±2 μ V$ ,whichever is greater	unknown	Thetriggeringof electricalstimulationis notadverse
Feedback threshold		$±10%or±2 μ V$ ,whichever is greater	unknown	affected
Compliance with VoluntaryStandards?		IEC 60601-1IEC 60601-1-2IEC 60601-2-10IEC 60601-2-40	IEC 60601-1IEC 60601-1-2IEC 60601-2-10	SE
	Compliance with 21 CFR 898	Yes	Yes	Same
Weight		3.8kg	330g
	Dimensions (mm) [W x H x D]	359×289×202mm	10215251mm	Note 04
Parameter	Subject Device	Predicate DeviceK053326	Remarks
Maximum OutputVoltage (volts) (+/-20%)	NMES Mode:P1 ~ P6, P8 ~ P10,P12 ~ P29, P33, P37,P39, P41 ~P42.	50V@500Ω125V@ 2 kΩ125V@10 kΩ	50V@ 500 Ω100V@ 2 kΩ100V@ 10 kΩ	SEThe NMESModeof theSubject Deviceis compared tothe STIMModeof thePredicateDevice.
	NMES Mode:P7, P11, P30, P34.	48.4V@500Ω125V@ 2 kΩ125V@10 kΩ	50V@ 500 Ω100V@ 2 kΩ100V@ 10 kΩ
	NMES Mode:P31.	34.2V@500Ω125V@ 2 kΩ125V@10 kΩ	50V@ 500 Ω100V@ 2 kΩ100V@ 10 kΩ	The ETS
	NMES Mode:P32, P36, P40.	41.9V@500Ω125V@ 2 kΩ125V@10 kΩ	50V@ 500 Ω100V@ 2 kΩ100V@ 10 kΩ	Mode of theSubject Deviceis compared tothe Threshold
	NMES Mode:P35.	39.5V@500Ω125V@ 2 kΩ125V@10 kΩ	50V@ 500 Ω100V@ 2 kΩ100V@ 10 kΩ	Mode of thePredicateDevice.
	NMES Mode:P38.	44.8V@500Ω125V@ 2 kΩ125V@10 kΩ	50V@ 500 Ω100V@ 2 kΩ100V@ 10 kΩ	The PASMode of theSubject Deviceis compared tothe TriggeredMode of thePredicateDevice.
	NMES Mode:P43.	15V@500Ω60V@ 2 kΩ125V@10 kΩ	50V@ 500 Ω100V@ 2 kΩ100V@ 10 kΩ
	ETS Mode.	23.7V@500Ω94.6V@ 2 kΩ125V@10 kΩ	50V@ 500 Ω100V@ 2 kΩ100V@ 10 kΩ	The MirrorMode of theSubject Deviceis compared tothe TriggeredMode of thePredicateDevice.
	PAS Mode.	50V@500Ω125V@ 2 kΩ125V@10 kΩ	50V@ 500 Ω100V@ 2 kΩ100V@ 10 kΩ
	MIRROR Mode.	50V@500Ω125V@ 2 kΩ125V@10 kΩ	50V@ 500 Ω100V@ 2 kΩ100V@ 10 kΩ
Maximum OutputCurrent (specifyunits)(+/-20%)	NMES Mode:P1~~P6, P8 ~ P10,P12~~ P29, P33, P37,P39, P41~P42.	100mA@500Ω62.5mA@ 2 kΩ12.5mA@10 kΩ	100.0mA@500Ω50mA@ 2 kΩ10mA@10 kΩ	SEThe NMESModeof theSubject Deviceis compared tothe STIMModeof thePredicateDevice.
	NMES Mode:P7, P11, P30, P34.	96.8mA@500Ω62.5mA@ 2 kΩ12.5mA@10 kΩ	100.0mA@500Ω50mA@ 2 kΩ10mA@10 kΩ
	NMES Mode:P31.	68.4mA@500Ω62.5mA@ 2 kΩ12.5mA@10 kΩ	100.0mA@500Ω50mA@ 2 kΩ10mA@10 kΩ
	NMES Mode:	83.8mA@500Ω	100.0mA@500Ω
Parameter	Subject Device	Predicate DeviceK053326	Remarks
	P32, P36, P40.	62.5mA@ 2 kΩ12.5mA@10 kΩ	50mA@ 2 kΩ10mA@10 kΩ	The ETSMode of theSubject Deviceis compared tothe ThresholdMode of thePredicateDevice.
	NMES Mode:P35.	79mA@500Ω62.5mA@ 2 kΩ12.5mA@10 kΩ	100.0mA@500Ω50mA@ 2 kΩ10mA@10 kΩ
	NMES Mode:P38.	89.6mA@500Ω62.5mA@ 2 kΩ12.5mA@10 kΩ	100.0mA@500Ω50mA@ 2 kΩ10mA@10 kΩ
	NMES Mode:P43.	30mA@500Ω30mA@ 2 kΩ12.5mA@10 kΩ	100.0mA@500Ω50mA@ 2 kΩ10mA@10 kΩ	The PASMode of theSubject Deviceis compared tothe TriggeredMode of thePredicateDevice.
	ETS Mode.	47.4mA@500Ω47.4mA@ 2 kΩ12.5mA@10 kΩ	100.0mA@500Ω50mA@ 2 kΩ10mA@10 kΩ
	PAS Mode.	100mA@500Ω62.5mA@ 2 kΩ12.5mA@10 kΩ	100.0mA@500Ω50mA@ 2 kΩ10mA@10 kΩ	The MirrorMode of theSubject Deviceis compared tothe TriggeredMode of thePredicateDevice.
	MIRROR Mode.	100mA@500Ω62.5mA@ 2 kΩ12.5mA@10 kΩ	100.0mA@500Ω50mA@ 2 kΩ10mA@10 kΩ
PulseDuration/width† (usec)	NMES Mode:P1.	250µs	50-400µs	SE
	NMES Mode:P2, P14, P24.	150µs	50-400µs	SE
	NMES Mode:P3, P16, P19, P26.	50µs	50-400µs	SE
	NMES Mode:P4.	45µs	50-400µs	SE
	NMES Mode:P5~P12, P18, P28, P41,P42.PAS Mode.MIRROR Mode.	200µs	50-400µs	SE
	NMES Mode:P13, P17, P21~P23, P25,P35.	300µs	50-400µs	SE
	NMES Mode:P15, P20, P27, P39.	100µs	50-400µs	SE
	NMES Mode:P29~~P34, P36~~P38, P40.	400µs	50-400µs	SE
	NMES Mode:P46.	50-500µs	50-400µs	SE
Parameter	Subject Device	Predicate DeviceK053326	Remarks
Frequency† (Hz) [orRate† (pps)]	NMES Mode:P1, P5, P9, P13, P17,P21, P25, P29, P33,P37, P41.	5Hz	2-100Hz	SE
	NMES Mode:P2, P15, P18, P23,P38.	35Hz	2-100Hz	SE
	NMES Mode:P3, P7, P11, P19, P26,P31,P35, P39.	60Hz	2-100Hz	SE
	NMES Mode:P4.	100Hz	2-100Hz	SE
	NMES Mode:P6, P30, P34.MIRROR Mode.	30Hz	2-100Hz	SE
	NMES Mode:P8.	45Hz	2-100Hz	SE
	NMES Mode:P10, P12, P16, P20,P24, P27, P28, P32,P36, P40,P42.	40Hz	2-100Hz	SE
	NMES Mode:P14, P22.	25Hz	2-100Hz	SE
	NMES Mode:P43.	2~250Hz	2-100Hz	SE
	ETS Mode.	2-100Hz	2-100Hz	SE
	PAS Mode.	18Hz	2-100Hz	SE
For interferentialmodes only:-Beat Frequency(Hz)	NMES Mode:P1~P43, ETS Mode,PAS Mode,MIRROR Mode.	N/A	N/A	/
For Symmetricalmultipha phases?	NMES Mode:P1~P43, ETS Mode,PAS Mode,MIRROR Mode.	N/A	N/A	/
ms only: PhaseDuration† (include units),(state range,if applicable),(bothphases, ifasymmetrical)	NMES Mode:P1~P43, ETS Mode,PAS Mode,MIRROR Mode.	N/A	N/A	/
Net Charge(microcoulombs(µC) per pulse) (Ifzero, state methodof achieving zero	NMES Mode:P1~P43, ETS Mode,PAS Mode,MIRROR Mode	0@500Ω	0@500Ω	Same
Parameter	Subject Device	Predicate DeviceK053326	Remarks
net charge.)
Maximum PhaseCharge, (µC)	NMES Mode:P1, P6.	25@500Ω	60@500Ω	SE
	NMES Mode:P2, P14, P24,	15@500Ω	60@500Ω
	NMES Mode:P3, P16, P19, P26.	5@500Ω	60@500Ω
	NMES Mode:P4,P15, P20, P27,P39.	10@500Ω	60@500Ω
	NMES Mode:P5, P8~P10, P12, P18,P28, P41, P42.PAS Mode.MIRROR Mode.	20@500Ω	60@500Ω
	NMES Mode:P7, P11.	19.36@500Ω	60@500Ω
	NMES Mode:P13, P17, P21~P23,P25.	30@500Ω	60@500Ω
	NMES Mode:P29, P33, P37.	40@500Ω	60@500Ω
	NMES Mode:P30, P34,.	38.72@500Ω	60@500Ω
	NMES Mode:P31.	27.36@500Ω	60@500Ω
	NMES Mode:P32, P36, P40.	33.52@500Ω	60@500Ω
	NMES Mode:P35.	23.7@500Ω	60@500Ω
	NMES Mode:P38.	35.84@500Ω	60@500Ω
	NMES Mode:P43.ETS Mode.	50@500Ω	60@500Ω
Maximum CurrentDensity,††(mA/cm².)	NMES: P43.	0.38977@500Ω(EC001)0.14696@500Ω(EC002)	Axelgaard Model8952200.24mA/cm2Axelgaard Model8953400.08mA/cm2	Note 05
Maximum PowerDensity,†† (mW/cm²), (using smallestelectrodeconductive surfacearea)	NMES: P30, P34, P43.	11.69@500Ω(EC001)4.41@500Ω(EC002)	Axelgaard Model89522016mW/cm2Axelgaard Model8953405.3mW/cm2	Note 06
Parameter	Subject Device	Predicate DeviceK053326	Remarks
Burst Mode(i.e., pulse trains):	(a) Pulses per burst	2~6000	4-2000	Note 07
	(b) Bursts per second	0.05~1	0.05-0.5	/
	(c) Burst duration (seconds)	1~20	2-20	/
	(d) Duty Cycle: Line (b) x Line (c)	1	1	Same
ON Time (seconds)		1~20	2-20	/
OFF Time (seconds)		1~20	2-50	/

Note 02: DC adaptor meets IEC 60601-1 standard.

Note 03: The subject device is powered by AC, not battery.

Note 04: The subject device is not a portable device.

{8}------------------------------------------------

510(K) Summary

Product: Nerve and Muscle Stimulator

Version: A/1

Table 03: SE Detailed Comparison Table

{9}------------------------------------------------

510(K) Summary

Product: Nerve and Muscle Stimulator

Version: A/1

{10}------------------------------------------------

510(K) Summary

Product: Nerve and Muscle Stimulator

Version: A/1

{11}------------------------------------------------

510(K) Summary

Product: Nerve and Muscle Stimulator

Version: A/1

{12}------------------------------------------------

510(K) Summary

Product: Nerve and Muscle Stimulator

Version: A/1

Note 05: The treatment effect is mainly determined by Maximum Power Density.

Note 06: The Maximum Power Density at this level is effective, for instance, Maximum Power Density is effective when it is as small as 1.38 mW/cm2 (K172933), 1.44 mW/cm2 (K182203, model PL-029K12) , 1.26 mW/cm2 (K182203, model PL-029K13: ), 1.68 mW/cm2 (K191151, model PL-029K15) and even as low as 0. 32 mW/cm2 (K162517, PL-029K12, P3.)

Note 07: subject device's pulses per burst rate is significantly different than the predicate device, but the duty cycle of the subject device is same as the duty cycle of the predicate, so the differences do not affect safety and effectiveness of the subject device.

Maximum Output Voltage, Maximum Output Current, Pulse Duration/width, Frequency range of the subject device are respectively SE to or similar with the predicate; there are little differences between the Maximum Current Density, Maximum Power Density, Burst Mode (i.e., pulse trains) of the subject device and the predicate, but the differences do not exert adverse effect on the proposed device.

7 Brief discussion of the nonclinical tests

The subject device conforms to the following standards:

60601-1:2005+CORR.1:2006+CORR.2007+A1:2012 IEC Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential

{13}------------------------------------------------

Shenzhen XFT Medical Limited	510(K) Summary
Product: Nerve and Muscle Stimulator	Version: A/1

Performance.

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

IEC 60601-2-40:2016 Medical Electrical Equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment

IEC 60601-2-10:2016 Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators

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 and Skin Sensitization.

8 Brief discussion of clinical tests

N/A.

9 Other information (such as required by FDA guidance/Test) No.

10 Conclusions

The subject device has features that are similar to the predicate device. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).