Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on standard electrical stimulation technology and software verification/validation, with no mention of AI or ML. The parameters are controlled by physical buttons and adjustable intensity, which is typical for non-AI/ML stimulators.

Therapeutic

Yes

The device descriptions and intended use clearly state that these devices are Transcutaneous Electrical Nerve Stimulators and Electrical Muscle Stimulators used for pain relief, muscle relaxation, muscle re-education, and other therapeutic purposes.

Diagnostic

No

The device description and intended use indicate that these are stimulators used for pain relief, muscle stimulation, and improving range of motion, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the devices are hardware units (Transcutaneous Electrical Nerve Stimulator and muscle stimulator) that send electrical current via electrodes and have physical controls like press buttons, an LCD display, and a keypad. While software is mentioned and validated, it is clearly embedded within a hardware device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The provided description clearly states that these devices are Transcutaneous Electrical Nerve Stimulators (TENS) and Electrical Muscle Stimulators (EMS). They work by applying electrical current to the skin to stimulate nerves and muscles for pain relief and muscle function.
Intended Use: The intended uses listed are all related to pain management and muscle stimulation, which are therapeutic applications, not diagnostic testing of biological samples.

Therefore, based on the provided information, these devices fall under the category of therapeutic medical devices, not In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Combo Stimulator MT9000
For TENS/IF/MIC mode

1. Symptomatic relief of chronic intractable pain
1. Post traumatic pain
1. Post surgical pain
For EMS mode
Relaxation of muscle spasm. 1.
1. Increase of local blood flow circulation
1. Prevention or retardation of disuse atrophy
1. Muscle re-education
1. Maintaining or increasing range of motion.
Immediate post-surgical stimulation of muscles to prevent venous thrombosis 6.

Combo Stimulator LT7102
For TENS/IF/MIC mode

Symptomatic relief of chronic intractable pain 1.
1. Post traumatic pain
1. Post surgical pain

For EMS/RUSS mode

Relaxation of muscle spasm. 1.
1. Increase of local blood flow circulation
1. Prevention or retardation of disuse atrophy
Muscle re-education 4.
1. Maintaining or increasing range of motion.
1. Immediate post-surgical stimulation of muscles to prevent venous thrombosis

TENS Stimulator InTENSity 10

1. Symptomatic relief of chronic intractable pain
1. Post traumatic pain
1. Post surgical pain

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

IPF, GZJ, LIH

Device Description

MT9000, LT7102 and Intensity 10 are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator sends gentle electrical current to underlying nerves and muscle group via electrode applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients.

The 3 models MT9000, LT7102 and Intensity 10 have similar housing with a viewable LCD display, an accessible keypad, and accessible battery storage compartment. The LCD is located on the upper half of the rectangular face of the device, above the keypad. The LCD is used to display system information to the user.

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

Not Found

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)

The following performance data are provided in support of the substantial equivalence determination:

Biocompatibility testing
Compared with unmodified device, the new product MT9000 and Intensity 10 has the same accessories which has been evaluated based on the ISO10993 standard and submits to FDA (K093138).

The new product LT7102 added the electrode accessories like as different part electrode belt previously had been submitted with Shenzhen Dongdixin Technology Co., Ltd (K141076) which has been evaluated based on the ISO10993 standard and submit to FDA.

Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the LT2061. The system complies with the IEC 60601-1 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern. IEC 62304 was followed.

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.

K093138, K071137

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

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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 and 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.

October 2, 2017

Shenzhen Dongdixin Technology Co., Ltd. Siping Yuan R.A. Specialist No. 3 Building Xilibaimang Xusheng Industrial Estate Nanshan Shenzhen, 518108 CN

Re: K171978

Trade/Device Name: Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ, LIH Dated: June 15, 2017 Received: July 5, 2017

Dear Siping Yuan:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Vivek J. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K171978

Device Name

Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10

Indications for Use (Describe)

Combo Stimulator MT9000

For TENS/IF/MIC mode

1. Symptomatic relief of chronic intractable pain
1. Post traumatic pain
1. Post surgical pain
For EMS mode
Relaxation of muscle spasm. 1.
1. Increase of local blood flow circulation
1. Prevention or retardation of disuse atrophy
1. Muscle re-education
న. Maintaining or increasing range of motion.
Immediate post-surgical stimulation of muscles to prevent venous thrombosis 6.

Combo Stimulator LT7102

For TENS/IF/MIC mode

Symptomatic relief of chronic intractable pain 1.
1. Post traumatic pain
1. Post surgical pain

For EMS/RUSS mode

Relaxation of muscle spasm. 1.
1. Increase of local blood flow circulation
1. Prevention or retardation of disuse atrophy
Muscle re-education 4.
న. Maintaining or increasing range of motion.
1. Immediate post-surgical stimulation of muscles to prevent venous thrombosis

TENS Stimulator InTENSity 10

1. Symptomatic relief of chronic intractable pain
1. Post traumatic pain
1. Post surgical pain

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.

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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:

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Image /page/4/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue, except for the X in DIXIN, which is in yellow. There are also three Chinese characters to the right of the English text.

001_510 (k) Summary Version: 1.1

510(k) SUMMARY

as required by section 21 CFR 807.92

Date of Submission:	06/15/2017
Submitter's Name:	Shenzhen Dongdixin Technology Co., Ltd
Address:	No. 3 Building, Xilibaimang Xusheng Industrial
Estate Nanshan, Shenzhen, CHINA 518108
E-mail:	yuansp@dundex.com
Tel:	+86(755) 27652471
FAX:	+86(755) 27652674
Contact:	Siping Yuan

5

DO TECHNOLOGY CO., L

001_510 (k) Summary Version: 1.1

1. Proposed Device:

| Trade Name: | Combo Stimulator MT9000
Combo Stimulator LT7102
TENS Stimulator Intensity 10 |
|----------------------|------------------------------------------------------------------------------------|
| Classification Name: | Stimulator, Muscle, Powered |
| Regulation Number: | 890.5850 |
| Product Code: | IPF |
| Device Class: | II |
| Trade Name: | Combo Stimulator MT9000
Combo Stimulator LT7102 |
| Classification Name: | Stimulator, Nerve, Transcutaneous. For pain relie- |
| Regulation Number: | 882.5890 |
| Product Code: | GZJ |
| Device Class: | II |

| Trade Name: | Combo Stimulator MT9000
Combo Stimulator LT7102 |
|----------------------|----------------------------------------------------|
| Classification Name: | Interferential current therapy |
| Regulation Number: | Unclassified |
| Product Code: | LIH |
| Device Class: | II |

2. Predicate Device:

Legally Marketed Device:	MT9000 Series Electro-Stimulator
510(k) Number:	K093138
Manufacturer:	Shenzhen Dondixin Technology Co., Ltd.
Legally Marketed Device:	Sonicator® Plus 940, ME940
510(k) Number:	K071137
Manufacturer:	Mettler Electronics Corp.

3. Description of Proposed Device:

MT9000, LT7102 and Intensity 10 are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator sends gentle electrical current to underlying nerves and muscle group via electrode applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according

6

Image /page/6/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue, except for a diagonal line in the middle of the word "DONGDIXIN", which is in orange. To the right of the company name are three Chinese characters in blue. The words "TECHNOLOGY CO., LTD." are in a smaller font size and are located below the company name.

to the needs of patients.

The 3 models MT9000, LT7102 and Intensity 10 have similar housing with a viewable LCD display, an accessible keypad, and accessible battery storage compartment. The LCD is located on the upper half of the rectangular face of the device, above the keypad. The LCD is used to display system information to the user.

4. Description of All Device Modification(s)

The Combo Stimulator MT9000 only changes the energy type and added the adapter power supply. Compared with the existing device (MT9000), they have the same control mechanism, IFU, operating principle, performance specification, dimensional specifications, materials and software. The new change part have been evaluated and passed the requirement based on IEC60601-1-2 and IEC60601-2-10.

The Combo Stimulator LT7102 change the 9-volt battery to the recharge Lithium battery, add the electrode accessories like as different part electrode belt and make it more convenient for the user. Meanwhile, we added the RUSSIAN electrical stimulation mode that together with the TENS, IF and MICROCURRENT. Compared with the existing device (MT9000), they have the same control mechanism, IFU, operating principle, materials and performance specification. And this modification does not affect the intended use of the device or alter the fundamental scientific technology of the device. The new change part have been evaluated and passed the requirement based on IEC60601-1, IEC60601-1-2 and IEC60601-2-10.

Compared with the existing device (MT9001), The TENS Stimulator Intensity 10 only has TENS mode and the following parts have changed:

Changes the energy type and added the adapter power supply. 1)
1. Change the dimensional specification.
Change the LCD UI and make it more convenient for the user. 3)

And these changes have been evaluated and passed the requirement based on IEC60601-1, IEC60601-1-2 and IEC60601-2-10.

5. Proposed Device Intended for Use Statement:

Device Name: Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator Intensity 10

Indications for Use:

Combo Stimulator MT9000

For TENS/IF/MIC mode

1. Symptomatic relief of chronic intractable pain
1. Post traumatic pain
1. Post surgical pain

For EMS mode

7

DON TECHNOLOGY CO., L

001 510 (k) Summary Version: 1.1

1. Relaxation of muscle spasm.
1. Increase of local blood flow circulation
1. Prevention or retardation of disuse atrophy
1. Muscle re-education
1. Maintaining or increasing range of motion.
1. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

Combo Stimulator LT7102

For TENS/IF/MIC mode

1. Symptomatic relief of chronic intractable pain
1. Post traumatic pain
1. Post surgical pain
For EMS/RUSS mode
1. Relaxation of muscle spasm.
1. Increase of local blood flow circulation
1. Prevention or retardation of disuse atrophy
1. Muscle re-education
1. Maintaining or increasing range of motion.
1. Immediate post-surgical stimulation of muscles to prevent venous thrombosis

TENS Stimulator Intensity 10

1. Symptomatic relief of chronic intractable pain
1. Post traumatic pain
1. Post surgical pain

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Image /page/8/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue and orange. The text "DONGDIXIN" is in large, bold, blue letters, with an orange "X". Below that, the text "TECHNOLOGY CO., LTD." is in smaller, blue letters.

6. Technological Characteristics and Substantial Equivalence

		New device	New device	New device	Predicate device	Predicate device	Discussion
1	510K#	To be assigned	To be assigned	To be assigned	K093138	K071137	N/A
2	Device Name	Combo Stimulator
LT7102	Combo
Stimulator
MT9000	TENS Stimulator
Intensity 10	MT9000 Combo
TENS/EMS/IF/MIC
Stimulator	Sonicator Plus940	N/A
3	Manufacturer	Shenzhen Dongdixin Technology Co., Ltd.				Mettler Electronics	N/A
4	Intended for use	Combo Stimulator MT9000
For TENS/IF/MIC mode

Symptomatic relief of chronic intractable pain
Post traumatic pain
Post surgical pain
For EMS mode
Relaxation of muscle spasm.
Increase of local blood flow circulation
Prevention or retardation of disuse atrophy
Muscle re-education
Maintaining or increasing range of motion.
Immediate post-surgical stimulation of calf muscles to
prevent venous thrombosis | | | For TENS/IF/MIC
mode
Symptomatic
relief of chronic
intractable pain
Post
traumatic pain
post surgical
pain
For EMS mode
Relaxation of
muscle spasm.
Increase of
local blood flow
circulation
Prevention
or retardation of
disuse atrophy
Muscle
re-education
Maintaining
or increasing
range of motion | 4-Pole Interferential,
2-Pole Interferential,
TENS and
Microcurrent
waveforms
Symptomatic relief
of chronic intractable
pain
Post-traumatic
pain
Post-surgical pain
EMS, TENS, Hi Volt
and Russian
waveforms
I. Relaxation of
muscle spasms
Increase local
blood circulation
Prevention or
retardation of disuse
atrophy
Muscle
re-education | Same |
| | | Combo Stimulator LT7102
For TENS/IF/MIC mode
Symptomatic relief of chronic intractable pain
Post traumatic pain
Post surgical pain | | | | | |
| | | | | | | | |
| | | For EMS/RUSS mode
Relaxation of muscle spasm.
Increase of local blood flow circulation
Prevention or retardation of disuse atrophy
Muscle re-education
Maintaining or increasing range of motion.
Immediate post-surgical stimulation of muscles to prevent venous thrombosis | | | 6. Immediate
post-surgical
stimulation of
muscles to
prevent venous
thrombosis | 5. Maintaining or
increasing range of
motion
Immediate post
surgical stimulation
of calf muscles to
prevent venous
thrombosis | |
| | | TENS Stimulator Intensity 10
Symptomatic relief of chronic intractable pain
Post traumatic pain
Post surgical pain | | | | | |
| 5 | Power Source | 3.7V Li-ion Battery
Charger output: 5.0V
DC, 300mA | 9V Battery
Adapter Output: 9V
DC 0.8A | 9V Battery
Adapter Output: 9V
DC 0.8A | 9V Battery | AC Line | Different, but they all
comply with IEC 60601-1
requirements. |
| | Method of Line current
isolation | N/A | N/A | N/A | Battery Supply N/A | Reinforced insulation | |
| | - Patient Leakage
Current
-Normal condition | 5 uA | 4 uA | 1 uA | 0.61uA | >50uA | |
| | -Single fault condition | 5 uA | 4 uA | 9 uA | 0.68uA | >50uA | |
| 6 | Number of Output
Modes | 5 | 4 | 1 | MT9000 4
MT9001 1
MT9002 1
MT9003 1
MT9004 1 | 8 | Different, the number of
output mode is the feature
of device, doesn't affect the
safety and effectiveness |
| 7 | Number of Output
Channels | 2 | 2 | 2 | 2 | 4 | Different, the number of
output channels is the
feature of device, doesn't |
| | - Synchronous or
Alternating? | Synchronous and
Alternating | Synchronous and
Alternating | Synchronous | Synchronous and
Alternating | Synchronous and
Alternating | affect the safety and
effectiveness |
| | - Method of Channel
Isolation? | By enclosure | By enclosure | By enclosure | By enclosure | By transformer | Different, but they all
comply with IEC 60601-1
requirements. |
| 8 | Constant Current?
Constant Voltage? | Yes
No | Yes
No | Yes
No | Yes
No | Yes
No | Same |
| 9 | Software/Firmware/
Microprocessor
Control? | Yes | Yes | Yes | Yes | Yes | Same |
| 10 | Automatic Overload
Trip?
Automatic Over Current
Trip? | Yes
Yes | Yes
Yes | Yes
Yes | Yes
Yes | Yes
Yes | Same |
| 11 | Automatic No Load
Trip? | Yes | Yes | Yes | Yes | Yes | Same |
| 12 | Automatic Shut off? | Yes | Yes | Yes | Yes | Yes | Same |
| 13 | Patient Override
Control? | No | No | No | No | No | Same |
| 14 | Indicator Display
-On/Off Status?
-Voltage/Current Level?
-Low Battery? | Yes
Yes
Yes | Yes
Yes
Yes | Yes
Yes
Yes | Yes
Yes
Yes | Yes
Yes
N/A | Same
Same
Same |
| 15 | Waveform
TENS
EMS
Interferential
Microcurrent
Russian | Biphasic
Biphasic
Biphasic
Monophasic
Biphasic | Biphasic
Biphasic
N/A
N/A
N/A | Biphasic
Biphasic
N/A
N/A
N/A | Biphasic
Biphasic
Biphasic
Monophasic
N/A | Biphasic
Biphasic
Biphasic
Monophasic or
Biphasic | Similar |

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Image /page/9/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue, except for a yellow line that crosses the "X" in "DIXIN". There are also three Chinese characters to the right of the English text.

10

Image /page/10/Picture/0 description: The image shows the logo for DONGDIXIN Technology Co., LTD. The logo is in blue and yellow. The text "DONGDIXIN" is in large, bold, blue letters, and the text "TECHNOLOGY CO., LTD." is in smaller, blue letters below it. To the right of the English text is the company name in Chinese.

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Image /page/11/Picture/0 description: The image shows the logo for DONGDIXIN Technology Co., LTD. The logo is in blue and yellow. The text "DONGDIXIN" is in large, bold, blue letters, and the text "TECHNOLOGY CO., LTD." is in smaller, blue letters below it. To the right of the English text is the company name in Chinese.

16	Shape					Biphasic
	TENS	Square	Square	Square	Square	Square	Same with unmodified
device MT9000, different
	EMS	Square	Square	N/A	Square	Sinusidal	from Sonicator Plus940.
	Interferential	Square	Square	N/A	Square	Sinusidal	The shape is the feature
	Microcurrent	Square	Square	N/A	Square	Square	of device, doesn't affect
	Russian	Square	N/A	N/A	N/A	Gated Sinusoidal	the safety and
effectiveness
17	Max Output Voltage (V) ±20%
	500Ω						Similar with unmodified
	TENS	50	48	52.5	48	50	device MT9000, different
	EMS	50	48	N/A	48	49	from Sonicator Plus940,
	Interferential	15.75	17.5	N/A	17.5	49	they all comply with IEC
	Microcurrent	0.4	0.36	N/A	0.36	0.38	60601-2-10.
	Russian	15.75	N/A	N/A	N/A	50
18	Max Output Current (mA) ±20%
	500Ω						Similar with unmodified
	TENS	100	96	105	96	100	device MT9000, different
	EMS	100	96	N/A	96	98	from Sonicator Plus940,
	Interferential	31.5	35	N/A	35	98	they all comply with IEC
	Microcurrent	0.8	0.76	N/A	0.76	0.76	60601-2-10.
	Russian	31.5	N/A	N/A	N/A	100
19	Pulse Width Range						Similar with unmodified
	TENS	50-400us	50-300us	100us~260us	50-300us	50-300us	device MT9000, different
	EMS	200~400us	50-300us	N/A	50-300us	500,250,200us	from Sonicator Plus940,
	Interferential	100/200/400us	125us	N/A	125us	500,250,200us	they all comply with IEC
	Microcurrent	2-200ms	2-200ms	N/A	2-200ms	1.25ms-1.67s	60601-2-10.
	Russian	400us	N/A	N/A	N/A	400us
20	Frequency
	TENS	1~150Hz	0.5-150Hz	50~150Hz	0.5-150Hz	0.5-250Hz
	EMS	1~100Hz	1-150Hz	N/A	1-150Hz	2kHz,4kHz,5kHz
	Interferential	2.5K,5K,10K Hz	4kHz	N/A	4kHz	2kHz,4kHz,5kHz

	Microcurrent
Russian	1-150Hz
2.5kHz	1-150Hz
N/A	N/A
N/A	1-150Hz
N/A	0.3-400Hz
2.5kHz
21	Beat Frequency
Interferential	1-200Hz	1-150Hz	N/A	1-150Hz	1-250Hz
22	Timer Range (minutes)	5-90 minutes	0-60 minutes	15-60 minutes	0-60 minutes	0-60 minutes	Different, the treatment
time doesn't affect the
safety and effectiveness
23	Compliance with
Voluntary Standards?	IEC60601-1,
IEC60601-1-2,
IEC60601-2-10	IEC60601-1,
IEC60601-1-2,
IEC60601-2-10	IEC60601-1,
IEC60601-1-2,
IEC60601-2-10	IEC60601-1,
IEC60601-1-2,
IEC60601-2-10,
MDD93/42/EEC,
Annex II	IEC60601-1,
IEC60601-1-2,
IEC60601-2-10,
MDD93/42/EEC, Annex
II	Similar
24	Compliance with 21
CFR 898?	Yes	Yes	Yes	Yes	Yes	Same
25	Weight (Ibs.)	0.28	0.28	0.28	0.28	11	Different, the different
26	Dimensions (in.) H x W
x L	4.6x2.36x0.9	4.5x2.55x0.9	4.5x2.55x0.9	4.5x2.55x0.9	4.9x13.6x10.5	weight and dimension
doesn't affect the safety
and effectiveness.
27	Housing Materials &
Construction	Enclosure: ABS	Enclosure: ABS	Enclosure: ABS	Enclosure: ABS	Metal Casing	Different, but they all
comply with IEC 60601-1
requirements.

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7. Performance Date:

The following performance data are provided in support of the substantial equivalence determination:

6.1 Biocompatibility testing

Compared with unmodified device, the new product MT9000 and Intensity 10 has the same accessories which has been evaluated based on the ISO10993 standard and submits to FDA (K093138).

The new product LT7102 added the electrode accessories like as different part electrode belt previously had been submitted with Shenzhen Dongdixin Technology Co., Ltd (K141076) which has been evaluated based on the ISO10993 standard and submit to FDA.

6.2 Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the LT2061. The system complies with the IEC 60601-1 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC.

6.3 Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern. IEC 62304 was followed.

8. Conclusions:

The LT7102, MT9000 and Intensity 10 have the same intended use and technological characteristics as the predicate device of Sonicator Plus 940, Model ME940 device and MT9000 Combo TENS/EMS/IF/MIC Stimulator. Moreover, bench testing and safety report supplied in this submission demonstrates that the difference in the submitted models could maintain the same safety and effectiveness as that of predicate device. In the other words, those engineering difference do not affect the intended use or alter the fundamental scientific technology of the device. Thus, the LT7102, MT9000 and Intensity 10 are substantially equivalent to the predicate device.