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

K171978 · Shenzhen Dongdixin Technology Co., Ltd. · IPF · Oct 2, 2017 · Physical Medicine

Device Facts

• Record ID: K171978
• Device Name: Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
• Applicant: Shenzhen Dongdixin Technology Co., Ltd.
• Product Code: IPF · Physical Medicine
• Decision Date: Oct 2, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Combo Stimulator MT9000 For TENS/IF/MIC mode 1. Symptomatic relief of chronic intractable pain 2. Post traumatic pain 3. Post surgical pain For EMS mode 1. Relaxation of muscle spasm. 2. Increase of local blood flow circulation 3. Prevention or retardation of disuse atrophy 4. Muscle re-education 5. Maintaining or increasing range of motion. 6. 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 2. Post traumatic pain 3. Post surgical pain For EMS/RUSS mode 1. Relaxation of muscle spasm. 2. Increase of local blood flow circulation 3. Prevention or retardation of disuse atrophy 4. Muscle re-education 5. Maintaining or increasing range of motion. 6. Immediate post-surgical stimulation of muscles to prevent venous thrombosis TENS Stimulator Intensity 10 1. Symptomatic relief of chronic intractable pain 2. Post traumatic pain 3. Post surgical pain

Device Story

Device delivers electrical current to nerves/muscles via skin-applied electrodes; used for pain relief and muscle stimulation. User operates device via keypad and LCD display to adjust intensity levels. Powered by battery or adapter. Models include TENS, EMS, Interferential (IF), Microcurrent (MIC), and Russian (RUSS) stimulation modes. Healthcare providers or patients use device to manage pain or rehabilitate muscles. Output affects clinical decision-making by providing non-pharmacological pain management and physical therapy support. Benefits include pain reduction, improved circulation, and muscle function maintenance.

Clinical Evidence

Bench testing only. Includes electrical safety (IEC 60601-1, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), and software verification/validation (IEC 62304). Biocompatibility of electrodes evaluated per ISO 10993.

Technological Characteristics

Powered muscle/nerve stimulator. Materials: ABS enclosure. Energy: 3.7V Li-ion or 9V battery/adapter. Output: 2 channels, constant current. Modes: TENS, EMS, IF, MIC, RUSS. Connectivity: Standalone. Sterilization: N/A. Software: Microprocessor-controlled, moderate level of concern.

Indications for Use

Indicated for symptomatic relief of chronic intractable, post-traumatic, or post-surgical pain. EMS/RUSS modes indicated for muscle spasm relaxation, local blood flow increase, disuse atrophy prevention/retardation, muscle re-education, range of motion maintenance/increase, and post-surgical stimulation to prevent venous thrombosis.

Regulatory Classification

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.

Predicate Devices

• MT9000 Series Electro-Stimulator (K093138)
• Sonicator® Plus 940, ME940 (K071137)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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 [phone] or [phone] 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 [phone] or [phone] 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
- 2. Post traumatic pain
- 3. Post surgical pain
- For EMS mode
- Relaxation of muscle spasm. 1.
- 2. Increase of local blood flow circulation
- 3. Prevention or retardation of disuse atrophy
- 4. 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.
- 2. Post traumatic pain
- 3. Post surgical pain

For EMS/RUSS mode

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

## TENS Stimulator InTENSity 10

- 1. Symptomatic relief of chronic intractable pain
- 2. Post traumatic pain
- 3. 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.

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

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

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

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

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

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

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

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<br>Estate Nanshan, Shenzhen, CHINA 518108 |
| E-mail: | [e-mail] |
| Tel: | [phone] |
| FAX: | [phone] |
| Contact: | Siping Yuan |

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

## DO TECHNOLOGY CO., L

001_510 (k) Summary Version: 1.1

- 1. Proposed Device:
1)

2)

3)

| Trade Name: | Combo Stimulator MT9000<br>Combo Stimulator LT7102<br>TENS Stimulator Intensity 10 |
|----------------------|------------------------------------------------------------------------------------|
| Classification Name: | Stimulator, Muscle, Powered |
| Regulation Number: | 890.5850 |
| Product Code: | IPF |
| Device Class: | II |
| Trade Name: | Combo Stimulator MT9000<br>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<br>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)
- 2) 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
- 2. Post traumatic pain
- 3. Post surgical pain

For EMS mode

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

## DON TECHNOLOGY CO., L

001 510 (k) Summary Version: 1.1

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

## TENS Stimulator Intensity 10

- 1. Symptomatic relief of chronic intractable pain
- 2. Post traumatic pain
- 3. Post surgical pain

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

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<br>LT7102 | Combo<br>Stimulator<br>MT9000 | TENS Stimulator<br>Intensity 10 | MT9000 Combo<br>TENS/EMS/IF/MIC<br>Stimulator | Sonicator Plus940 | N/A |
| 3 | Manufacturer | Shenzhen Dongdixin Technology Co., Ltd. | | | | Mettler Electronics | N/A |
| 4 | Intended for use | Combo Stimulator MT9000<br>For TENS/IF/MIC mode<br>1. Symptomatic relief of chronic intractable pain<br>2. Post traumatic pain<br>3. Post surgical pain<br>For EMS mode<br>1. Relaxation of muscle spasm.<br>2. Increase of local blood flow circulation<br>3. Prevention or retardation of disuse atrophy<br>4. Muscle re-education<br>5. Maintaining or increasing range of motion.<br>6. Immediate post-surgical stimulation of calf muscles to<br>prevent venous thrombosis | | | For TENS/IF/MIC<br>mode<br>1. Symptomatic<br>relief of chronic<br>intractable pain<br>2. Post<br>traumatic pain<br>3. post surgical<br>pain<br>For EMS mode<br>1. Relaxation of<br>muscle spasm.<br>2. Increase of<br>local blood flow<br>circulation<br>3. Prevention<br>or retardation of<br>disuse atrophy<br>4. Muscle<br>re-education<br>5. Maintaining<br>or increasing<br>range of motion | 4-Pole Interferential,<br>2-Pole Interferential,<br>TENS and<br>Microcurrent<br>waveforms<br>1. Symptomatic relief<br>of chronic intractable<br>pain<br>2. Post-traumatic<br>pain<br>3. Post-surgical pain<br>EMS, TENS, Hi Volt<br>and Russian<br>waveforms<br>I. Relaxation of<br>muscle spasms<br>2. Increase local<br>blood circulation<br>3. Prevention or<br>retardation of disuse<br>atrophy<br>4. Muscle<br>re-education | Same |
| | | Combo Stimulator LT7102<br>For TENS/IF/MIC mode<br>1. Symptomatic relief of chronic intractable pain<br>2. Post traumatic pain<br>3. Post surgical pain | | | | | |
| | | | | | | | |
| | | For EMS/RUSS mode<br>1. Relaxation of muscle spasm.<br>2. Increase of local blood flow circulation<br>3. Prevention or retardation of disuse atrophy<br>4. Muscle re-education<br>5. Maintaining or increasing range of motion.<br>6. Immediate post-surgical stimulation of muscles to prevent venous thrombosis | | | 6. Immediate<br>post-surgical<br>stimulation of<br>muscles to<br>prevent venous<br>thrombosis | 5. Maintaining or<br>increasing range of<br>motion<br>6. Immediate post<br>surgical stimulation<br>of calf muscles to<br>prevent venous<br>thrombosis | |
| | | TENS Stimulator Intensity 10<br>1. Symptomatic relief of chronic intractable pain<br>2. Post traumatic pain<br>3. Post surgical pain | | | | | |
| 5 | Power Source | 3.7V Li-ion Battery<br>Charger output: 5.0V<br>DC, 300mA | 9V Battery<br>Adapter Output: 9V<br>DC 0.8A | 9V Battery<br>Adapter Output: 9V<br>DC 0.8A | 9V Battery | AC Line | Different, but they all<br>comply with IEC 60601-1<br>requirements. |
| | Method of Line current<br>isolation | N/A | N/A | N/A | Battery Supply N/A | Reinforced insulation | |
| | - Patient Leakage<br>Current<br>-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<br>Modes | 5 | 4 | 1 | MT9000 4<br>MT9001 1<br>MT9002 1<br>MT9003 1<br>MT9004 1 | 8 | Different, the number of<br>output mode is the feature<br>of device, doesn't affect the<br>safety and effectiveness |
| 7 | Number of Output<br>Channels | 2 | 2 | 2 | 2 | 4 | Different, the number of<br>output channels is the<br>feature of device, doesn't |
| | - Synchronous or<br>Alternating? | Synchronous and<br>Alternating | Synchronous and<br>Alternating | Synchronous | Synchronous and<br>Alternating | Synchronous and<br>Alternating | affect the safety and<br>effectiveness |
| | - Method of Channel<br>Isolation? | By enclosure | By enclosure | By enclosure | By enclosure | By transformer | Different, but they all<br>comply with IEC 60601-1<br>requirements. |
| 8 | Constant Current?<br>Constant Voltage? | Yes<br>No | Yes<br>No | Yes<br>No | Yes<br>No | Yes<br>No | Same |
| 9 | Software/Firmware/<br>Microprocessor<br>Control? | Yes | Yes | Yes | Yes | Yes | Same |
| 10 | Automatic Overload<br>Trip?<br>Automatic Over Current<br>Trip? | Yes<br>Yes | Yes<br>Yes | Yes<br>Yes | Yes<br>Yes | Yes<br>Yes | Same |
| 11 | Automatic No Load<br>Trip? | Yes | Yes | Yes | Yes | Yes | Same |
| 12 | Automatic Shut off? | Yes | Yes | Yes | Yes | Yes | Same |
| 13 | Patient Override<br>Control? | No | No | No | No | No | Same |
| 14 | Indicator Display<br>-On/Off Status?<br>-Voltage/Current Level?<br>-Low Battery? | Yes<br>Yes<br>Yes | Yes<br>Yes<br>Yes | Yes<br>Yes<br>Yes | Yes<br>Yes<br>Yes | Yes<br>Yes<br>N/A | Same<br>Same<br>Same |
| 15 | Waveform<br>TENS<br>EMS<br>Interferential<br>Microcurrent<br>Russian | Biphasic<br>Biphasic<br>Biphasic<br>Monophasic<br>Biphasic | Biphasic<br>Biphasic<br>N/A<br>N/A<br>N/A | Biphasic<br>Biphasic<br>N/A<br>N/A<br>N/A | Biphasic<br>Biphasic<br>Biphasic<br>Monophasic<br>N/A | Biphasic<br>Biphasic<br>Biphasic<br>Monophasic or<br>Biphasic | Similar |

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

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.

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

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<br>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<br>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<br>Russian | 1-150Hz<br>2.5kHz | 1-150Hz<br>N/A | N/A<br>N/A | 1-150Hz<br>N/A | 0.3-400Hz<br>2.5kHz | |
| 21 | Beat Frequency<br>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<br>time doesn't affect the<br>safety and effectiveness |
| 23 | Compliance with<br>Voluntary Standards? | IEC60601-1,<br>IEC60601-1-2,<br>IEC60601-2-10 | IEC60601-1,<br>IEC60601-1-2,<br>IEC60601-2-10 | IEC60601-1,<br>IEC60601-1-2,<br>IEC60601-2-10 | IEC60601-1,<br>IEC60601-1-2,<br>IEC60601-2-10,<br>MDD93/42/EEC,<br>Annex II | IEC60601-1,<br>IEC60601-1-2,<br>IEC60601-2-10,<br>MDD93/42/EEC, Annex<br>II | Similar |
| 24 | Compliance with 21<br>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<br>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<br>doesn't affect the safety<br>and effectiveness. |
| 27 | Housing Materials &<br>Construction | Enclosure: ABS | Enclosure: ABS | Enclosure: ABS | Enclosure: ABS | Metal Casing | Different, but they all<br>comply with IEC 60601-1<br>requirements. |

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

Image /page/12/Picture/0 description: The image is a logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue and orange. The word "DONGDIXIN" is in large, bold, blue letters, with the "X" in "DIXIN" being orange. Below "DONGDIXIN" is the text "TECHNOLOGY CO., LTD." in smaller, blue letters. To the right of the text is a column of three Chinese characters.

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

## 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.