Nerve and Muscle Stimulator

• K Number: K211094
• Device Name: Nerve and Muscle Stimulator
• Manufacturer: Shenzhen XFT Medical Limited
• Date Cleared: 2021-07-08 ( 87 days)
• Product Code: IPF HCC
• Regulation Number: 890.5850

Intended Use

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.

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.

Predicate Devices

K053266

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard electrical muscle stimulator and electromyography device with no mention of AI or ML capabilities in the intended use, device description, or performance studies.

Therapeutic

Yes.
The device's intended uses include relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, immediate post-surgical stimulation of calf muscles, maintaining or increasing range of motion, and stroke rehabilitation by muscle re-education, all of which are therapeutic applications.

Diagnostic

Yes

The device description explicitly states, "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." Monitoring and displaying bioelectric signals to assess muscle and nerve activity constitutes a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an electrical muscle stimulator and electromyography device powered by MAINS SUPPLY AC 100-240V, 50-60Hz, and used with Electrode cups. This indicates it is a hardware device with electrical components, not software only.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
• Device Function: The description clearly states the device is an electrical muscle stimulator and an electromyography device. It works by applying electrical stimulation to muscles and monitoring the electrical signals produced by muscles and nerves.
• Intended Use: The intended uses listed are related to muscle function, rehabilitation, and pain management, all of which involve direct interaction with the body or monitoring of physiological signals from the body, not the analysis of specimens taken from the body.
• Lack of Specimen Handling: There is no mention of collecting, preparing, or examining any type of biological specimen.

Therefore, the device's function and intended use fall outside the scope of In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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):

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.

Product codes (comma separated list FDA assigned to the subject device)

IPF, HCC

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K053266

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

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 ([e-mail]) or phone [phone] 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;

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.

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)

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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 Summary
prepared
Manufacturer
information | Apr., 6, 2021
Shenzhen XFT Medical Limited.
Company address:
Room 203, Building 1, Biomedicine Innovations
Industrial Park, #14 Jinhui Road, Pingshan New
District, Shenzhen, China.
Contact person: Cindy Peng
Phone: [phone]
Fax: [phone]
E-mail: [e-mail] |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission
Correspondent
Image: logo | Shenzhen Joyantech Consulting Co., Ltd.
Address: 1713A, 17th Floor, Block A,
Zhongguan Times Square, Liuxian Avenue, Xili
Town, Nanshan District, Shenzhen, Guangdong
Province, China.
Contact person: Mr. Field Fu
E-Mail: [e-mail]; |
| Establishment
registration 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

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.

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):

1. Relaxation of muscle spasms;

2. Prevention or retardation of disuse atrophy;

5

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

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.

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

| Elements of

Comparison	Subject Device	Predicate Device	Remarks
510(k) Number	Pending	K053266
Manufacturer	Shenzhen XFT Medical
Limited	Thought Technology Ltd.
Device
type/model	XFT-2003K	MYOTRAC INFINITI	/
Intended use/
Indication
for
use	sEMG:
Biofeedback, Relaxation &
Muscle Re-Education
purposes;
NMES (muscle stimulation)
and sEMG triggered
stimulation (IncludingETS,
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. | 1) Biofeedback, Relaxation and
   Muscle Re-Education purposes;
7. Relaxation of muscle spasms;
8. Prevention or retardation of
   disuse atrophy;
9. Increasing local blood
   circulation;
10. Immediate post-surgical
    stimulation of calf muscles to
    prevent venous thrombosis;
11. Maintaining or increasing
    range of motion.
12. Stroke Rehab by Muscle re-
    education. | SE |
    | Prescription
    or
    OTC | 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 of

Comparison	Subject Device	Predicate Device	Remarks
Waveform	Pulsed,Symmetrical balanced
biphasic wave (rectangular)	Asymmetrical balanced pulsed
current	SE
Performance	Compliance with IEC 60601-
2-10	Compliance with IEC 60601-2-
10	Same
Biocompatibility	All the patient contacting
materials are in compliance
with ISO 10993-1/-5/-10	All the patient contacting
materials are in compliance with
ISO 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
Connecting
Safety	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 and
Model	XFT-2003K	MYOTRAC INFINITI	/
Manufacturer	Shenzhen XFT Medical
Limited	Thought Technology Ltd.	/
Power Source(s)	AC 110-240 50-60Hz	4 AAA batteries, single use
alkaline or Rechargeable
battery pack	Note 02
---Method of Line Current
Isolation	2MOPP	2MOPP	Same
---Patient Leakage Current:
Normal Condition (μΑ)	$\u22641$	$\u22641$	Same
---Patient Leakage Current:
Single Fault Condition (μΑ)	$\u22641$	$\u22641$	Same
Number of Output
Modes(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 Regulated
Voltage?	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 Overload
Trip?	Yes	Yes	Same
Automatic No-Load Trip?	Yes	Yes	Same
Automatic Shut Off?	Yes	No	SE
Patient Override Control?	Yes	Yes	Same
Indicator
Display:	On/Off Status?	yes	Yes	Same
	Low Battery?	No.	Yes	Note 03
	Voltage/Current
Level?	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 frequency
bands(Hz)		20-500	20-500	Same
sEMG indication accuracy		$±10%or±2 μ V$ ,
whichever is greater	unknown	The
triggering
of electrical
stimulation
is not
adverse
Feedback threshold		$±10%or±2 μ V$ ,
whichever is greater	unknown	affected
Compliance with Voluntary
Standards?		IEC 60601-1
IEC 60601-1-2
IEC 60601-2-10
IEC 60601-2-40	IEC 60601-1
IEC 60601-1-2
IEC 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 Device
K053326	Remarks
Maximum Output
Voltage (volts) (+/-
20%)	NMES Mode:
P1 ~ P6, P8 ~ P10,
P12 ~ P29, P33, P37,
P39, P41 ~P42.	50V@500Ω
125V@ 2 kΩ
125V@10 kΩ	50V@ 500 Ω
100V@ 2 kΩ
100V@ 10 kΩ	SE
The NMES
Modeof the
Subject Device
is compared to
the STIMMode
of the
Predicate
Device.
	NMES Mode:
P7, P11, P30, P34.	48.4V@500Ω
125V@ 2 kΩ
125V@10 kΩ	50V@ 500 Ω
100V@ 2 kΩ
100V@ 10 kΩ
	NMES Mode:
P31.	34.2V@500Ω
125V@ 2 kΩ
125V@10 kΩ	50V@ 500 Ω
100V@ 2 kΩ
100V@ 10 kΩ	The ETS
	NMES Mode:
P32, P36, P40.	41.9V@500Ω
125V@ 2 kΩ
125V@10 kΩ	50V@ 500 Ω
100V@ 2 kΩ
100V@ 10 kΩ	Mode of the
Subject Device
is compared to
the Threshold
	NMES Mode:
P35.	39.5V@500Ω
125V@ 2 kΩ
125V@10 kΩ	50V@ 500 Ω
100V@ 2 kΩ
100V@ 10 kΩ	Mode of the
Predicate
Device.
	NMES Mode:
P38.	44.8V@500Ω
125V@ 2 kΩ
125V@10 kΩ	50V@ 500 Ω
100V@ 2 kΩ
100V@ 10 kΩ	The PAS
Mode of the
Subject Device
is compared to
the Triggered
Mode of the
Predicate
Device.
	NMES Mode:
P43.	15V@500Ω
60V@ 2 kΩ
125V@10 kΩ	50V@ 500 Ω
100V@ 2 kΩ
100V@ 10 kΩ
	ETS Mode.	23.7V@500Ω
94.6V@ 2 kΩ
125V@10 kΩ	50V@ 500 Ω
100V@ 2 kΩ
100V@ 10 kΩ	The Mirror
Mode of the
Subject Device
is compared to
the Triggered
Mode of the
Predicate
Device.
	PAS Mode.	50V@500Ω
125V@ 2 kΩ
125V@10 kΩ	50V@ 500 Ω
100V@ 2 kΩ
100V@ 10 kΩ
	MIRROR Mode.	50V@500Ω
125V@ 2 kΩ
125V@10 kΩ	50V@ 500 Ω
100V@ 2 kΩ
100V@ 10 kΩ
Maximum Output
Current (specify
units)
(+/-
20%)	NMES Mode:
P1~P6, P8 ~ P10,
P12~ P29, P33, P37,
P39, P41~P42.	100mA@500Ω
62.5mA@ 2 kΩ
12.5mA@10 kΩ	100.0mA@500Ω
50mA@ 2 kΩ
10mA@10 kΩ	SE
The NMES
Modeof the
Subject Device
is compared to
the STIMMode
of the
Predicate
Device.
	NMES Mode:
P7, P11, P30, P34.	96.8mA@500Ω
62.5mA@ 2 kΩ
12.5mA@10 kΩ	100.0mA@500Ω
50mA@ 2 kΩ
10mA@10 kΩ
	NMES Mode:
P31.	68.4mA@500Ω
62.5mA@ 2 kΩ
12.5mA@10 kΩ	100.0mA@500Ω
50mA@ 2 kΩ
10mA@10 kΩ
	NMES Mode:	83.8mA@500Ω	100.0mA@500Ω
Parameter	Subject Device	Predicate Device
K053326	Remarks
	P32, P36, P40.	62.5mA@ 2 kΩ
12.5mA@10 kΩ	50mA@ 2 kΩ
10mA@10 kΩ	The ETS
Mode of the
Subject Device
is compared to
the Threshold
Mode of the
Predicate
Device.
	NMES Mode:
P35.	79mA@500Ω
62.5mA@ 2 kΩ
12.5mA@10 kΩ	100.0mA@500Ω
50mA@ 2 kΩ
10mA@10 kΩ
	NMES Mode:
P38.	89.6mA@500Ω
62.5mA@ 2 kΩ
12.5mA@10 kΩ	100.0mA@500Ω
50mA@ 2 kΩ
10mA@10 kΩ
	NMES Mode:
P43.	30mA@500Ω
30mA@ 2 kΩ
12.5mA@10 kΩ	100.0mA@500Ω
50mA@ 2 kΩ
10mA@10 kΩ	The PAS
Mode of the
Subject Device
is compared to
the Triggered
Mode of the
Predicate
Device.
	ETS Mode.	47.4mA@500Ω
47.4mA@ 2 kΩ
12.5mA@10 kΩ	100.0mA@500Ω
50mA@ 2 kΩ
10mA@10 kΩ
	PAS Mode.	100mA@500Ω
62.5mA@ 2 kΩ
12.5mA@10 kΩ	100.0mA@500Ω
50mA@ 2 kΩ
10mA@10 kΩ	The Mirror
Mode of the
Subject Device
is compared to
the Triggered
Mode of the
Predicate
Device.
	MIRROR Mode.	100mA@500Ω
62.5mA@ 2 kΩ
12.5mA@10 kΩ	100.0mA@500Ω
50mA@ 2 kΩ
10mA@10 kΩ
Pulse
Duration/width† (use
c)	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, P
25,
P35.	300µs	50-400µs	SE
	NMES Mode:
P15, P20, P27, P39.	100µs	50-400µs	SE
	NMES Mode:
P29P34, P36P38, P

40.                                       | 400µs                                                            | 50-400µs                                                                                                                           | SE                                                                                                                    |
    

| | NMES Mode:
P46. | 50-500µs | 50-400µs | SE |
| Parameter | Subject Device | Predicate Device
K053326 | Remarks | |
| Frequency† (Hz) [or
Rate† (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. | 2250Hz | 2-100Hz | SE |
| | ETS Mode. | 2-100Hz | 2-100Hz | SE |
| | PAS Mode. | 18Hz | 2-100Hz | SE |
| For interferential
modes only:
-Beat Frequency
(Hz) | NMES Mode:
P1P43, ETS Mode,
PAS Mode,
MIRROR Mode. | N/A | N/A | / |
| For Symmetrical
multipha phases? | NMES Mode:
P1P43, ETS Mode,
PAS Mode,
MIRROR Mode. | N/A | N/A | / |
| ms only: Phase
Duration† (in
clude units),
(state range,
if applicable),
(both
phases, if
asymmetrical) | NMES Mode:
P1P43, ETS Mode,
PAS Mode,
MIRROR Mode. | N/A | N/A | / |
| Net Charge
(microcoulombs
(µC) per pulse) (If
zero, state method
of achieving zero | NMES Mode:
P1P43, ETS Mode,
PAS Mode,
MIRROR Mode | 0@500Ω | 0@500Ω | Same |
| Parameter | Subject Device | Predicate Device
K053326 | Remarks | |
| net charge.) | | | | |
| Maximum Phase
Charge, (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, P8P10, 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, P21P23,
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 Current
Density,††(mA/cm².) | NMES: P43. | 0.38977@500Ω
(EC001)
0.14696@500Ω
(EC002) | Axelgaard Model
895220
0.24mA/cm2
Axelgaard Model
895340
0.08mA/cm2 | Note 05 |
| Maximum Power
Density,†† (mW/cm²)
, (using smallest
electrode
conductive surface
area) | NMES: P30, P34, P43. | 11.69@500Ω
(EC001)
4.41@500Ω
(EC002) | Axelgaard Model
895220
16mW/cm2
Axelgaard Model
895340
5.3mW/cm2 | Note 06 |
| Parameter | Subject Device | Predicate Device
K053326 | Remarks | |
| Burst Mode
(i.e., pulse trains): | (a) Pulses per burst | 26000 | 4-2000 | Note 07 |
| | (b) Bursts per second | 0.051 | 0.05-0.5 | / |
| | (c) Burst duration (seconds) | 120 | 2-20 | / |
| | (d) Duty Cycle: Line (b) x Line (c) | 1 | 1 | Same |
| ON Time (seconds) | | 120 | 2-20 | / |
| OFF Time (seconds) | | 120 | 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.