Smart Pain Reliever, Model LT5019

K162479 · Shenzhen Dongdixin Technology Co., Ltd. · NUH · Feb 8, 2017 · Neurology

Device Facts

• Record ID: K162479
• Device Name: Smart Pain Reliever, Model LT5019
• Applicant: Shenzhen Dongdixin Technology Co., Ltd.
• Product Code: NUH · Neurology
• Decision Date: Feb 8, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities. And to be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

Device Story

Smart Pain Reliever (LT5019) is a home-use, OTC transcutaneous electrical nerve stimulator (TENS) and powered muscle stimulator (EMS). Device uses Bluetooth Low Energy to connect to a mobile app (iOS/Android) for control. Input: user selection of 11 TENS programs, 8 EMS programs, or 1 massage program via app. Device transforms inputs into biphasic, rectangular electrical pulses delivered through skin-surface electrodes. TENS modifies pain perception; EMS induces passive muscle contraction to facilitate performance/recovery. Output: electrical stimulation pulses. Healthcare provider/patient uses app to adjust intensity and monitor status via LED indicators (standby, treating, paused, connected). Device benefits include non-invasive, drug-free pain management and muscle conditioning. Operated by patient at home.

Clinical Evidence

Bench testing only. Includes biocompatibility (cytotoxicity, sensitization, irritation per ISO 10993-1), electrical safety/EMC (IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-10, 62133), software verification/validation (IEC 62304), and usability testing (IEC 62366). Performance testing characterized waveform and stimulus parameters to confirm design specifications.

Technological Characteristics

Materials: PC + ABS housing. Sensing/Actuation: Biphasic, rectangular waveform electrical stimulation via skin-surface electrodes. Energy: 3.7V rechargeable battery. Connectivity: Bluetooth Low Energy to mobile app. Software: Microprocessor-controlled, moderate level of concern. Standards: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 60601-1-11, ISO 10993-1/5/10.

Indications for Use

Indicated for adults for temporary relief of pain in shoulder, waist, back, neck, arms, and legs due to exercise or household strain; symptomatic relief of chronic, intractable pain; relief of arthritis-associated pain; and stimulation of healthy muscles to improve/facilitate muscle performance.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• PulseRelief (K151035)
• SmartRelief (K131159)
• Compex® Sport Plus "MASSAGE" program (K083140)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 8, 2017

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

Re: K162479

Trade/Device Name: Smart Pain Reliever, Model LT5019 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX, NYN Dated: August 15, 2016 Received: January 9, 2017

Dear Truman Shen:

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 requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Michael J. Hoffmann -S

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

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

#### 510(k) Number (if known)

#### K162479

Device Name Smart Pain Reliever Model: LT5019

#### Indications for Use (Describe)

TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities. And to be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

× Over-The-Counter Use (21 CFR 801 Subpart C)

#### 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 [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."

FORM FDA 3881 (8/14)

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## 510(k) SUMMARY

as required by section 21 CFR 807.92

Smart Pain Reliever

| Date of Submission: 08/15/2016 |
|---------------------------------------------------------------------------------------------------|
| 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: Truman Shen |

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TECHNOLOGY CO., LTD.

| 1. | Proposed Device: | |
|----|-------------------------------|-----------------------------------------------------------|
| | Device classification Name: | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| | Regulation Description: | Transcutaneous electrical nerve stimulator for pain relie |
| | Regulation Medical Specialty: | Neurology |
| | Review Panel: | Neurology |
| | Regulation Number: | 882.5890 |
| | Product Code: | NUH |
| | Device Class: | II |
| | Device classification Name: | Stimulator, Muscle, Powered, For Muscle Conditioning |
| | Regulation Description: | Powered muscle stimulator. |
| | Regulation Medical Specialty: | Physical Medicine |
| | Review Panel: | Physical Medicine |
| | Regulation Number: | 890.5850 |
| | Product Code: | NGX |
| | Device Class: | II |
| | Device classification Name: | Stimulator, Electrical, Transcutaneous, For Arthritis |
| | Regulation Description: | Transcutaneous electrical nerve stimulator for pain relie |
| | Regulation Medical Specialty: | Neurology |
| | Review Panel: | Neurology |
| | Regulation Number: | 882.5890 |
| | Product Code: | NYN |
| | Device Class: | II |

### 2. Predicate Device:

| No. | Legally Marketed Device: | 510(k) Number: | Manufacturer: |
|-----|-----------------------------------------|----------------|----------------------------|
| 1 | PulseRelief | K151035 | Philips Consumer Lifestyle |
| 2 | SmartRelief | K131159 | Chattem, Inc. |
| 3 | Compex® Sport Plus<br>"MASSAGE" program | K083140 | Compex S.A. |

#### 3. Description of Proposed Device:

LT5019 is designed to be used at home, by adults of all genders.

### Explanation of how the device functions:

The Smart Pain Reliever includes TENS, EMS (including MASSAGE Program). Transcutaneous Electrical Nerve Stimulation (TENS) is a noninvasive, drug free method of controlling pain. EMS works by sending electronic pulses to the muscle needing treatment; this causes the muscle to exercise passively.

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Image /page/5/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is composed of the company name in a bold, sans-serif font, with the "X" in "DIXIN" stylized in orange. To the right of the English name is the company name in Chinese characters.

#### Scientific concepts that from the basis for the device:

TENS uses tiny electrical impulses sent through the skin to nerves to modify your pain perception. TENS does not cure any physiological problem; it only helps control the pain, this activates the underlying sensory nerves. EMS is a product derived from the square waveform (ladder - shaped), through the square wave pattern it is able to work directly on muscle motor neurons, contraction helps to condition the muscle in order to facilitate performance.

For Transcutaneous Electrical Nerve Stimulation (TENS) Self-adhesive electrodes are placed on the skin close to the area of pain. The user can choose 11 pre-set TENS programs with different pulse settings. In each program, the intensity of the pulse can be adjusted.

For Electrical Muscle Stimulation (EMS), the electrodes are placed near the muscle to be stimulated. The user can choose 8 pre-set EMS programs with different pulse settings. In each program, the intensity of the pulse can be adjusted.

The Smart Pain Reliever device only have one massage program, and this massage stimulation program is a stimulation program that is used with the EMS mode of stimulation to facilitate recovery from muscle fatigue and to help recover muscle strength after training sessions and competitions.

### The functions of the LT5019 device:

The Smart Pain Reliever device is controlled by means of an APP on a mobile device (phone or table). The communication is done via Bluetooth Low Energy. The APP operates on IOS and Android platforms (IOS 8.0 or greater, Android 5.0 or greater).

| Control/Indicator | User interface | Function |
|-------------------|-----------------------------------|-------------------------------------------------------------------------|
| On/off Button | Press button (when device is off) | Turn on the device |
| | Press button (when device is on) | Turn off the device (at any time, before, during or after treatment ) |
| LED indicator | off | Device off |
| | Green flashing | It means that the device is in standby mode |
| | Orange continuous | It means in treating mode or the battery is being charging |
| | Orange flashing | It means that the device is in paused mode |
| | Green continuous | It means it has connected with APP or the battery is full when charging |

Table 1: Smart Pain Reliever device controls and indicators

## 4. Proposed Device Intended for Use Statement:

Device Name: Smart Pain Reliever, Model: LT5019

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Image /page/6/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue and orange, with the company name in English and Chinese. The English name is in a bold, sans-serif font, and the Chinese name is in a traditional font. The logo is simple and modern, and it is likely used on the company's website and marketing materials.

#### Indications for Use:

- � TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities. And to be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
- � EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

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Image /page/7/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue and yellow. The text is in a sans-serif font. The logo is simple and modern.

#### 5. Technological Characteristics and Substantial Equivalence

Both the LT5019 and Predicate Device utilize the application of electrodes placed on the skin for pain control, or electrical muscle stimulation (EMS) the elicitation of muscle contraction using electric impulses are generated by the device and delivered through electrodes on the skin in direct proximity to the (painful) muscles to be stimulated.

Basic technological characteristics, new device vs. Predicate device

| | | New device | Predicate device | | Remark | or Regulated<br>Voltage? | | | | | | | | | |
|---|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|--------------|---------------------------------------------------|-------------------------------------|---------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|------------------------|---------------------|--------------|
| 1 | 510K# | K162479 | K151035 | K131159 | K083140 | -- | 10 | Software/Firmware<br>/Micro processor<br>Control? | | Yes | Yes | Yes | Yes | Same | |
| 2 | Device Name and<br>Model | Smart Pain Reliever<br>Mode: LT5019 | PulseRelief | SmartRelief | Compex® Sport<br>Plus<br>"MASSAGE"<br>program | -- | 11 | Automatic<br>Overload Trip | | Yes | Yes | No | No | SE<br>Note 2 | |
| 3 | Manufacturer | Dongdixin Technology Co.,<br>Ltd | Philips Consumer Lifestyle | Chattem, Inc. | Compex S.A. | -- | 12 | Automatic No<br>Load contact Trip | | Yes | Yes | No | Yes | SE<br>Note 2 | |
| 4 | Intended for use | TENS: The device is<br>designed to be used for<br>temporary relief of pain<br>associated with sore and<br>aching muscles in the<br>shoulder, waist, back, neck,<br>upper extremities(arm) and<br>lower extremities (leg) due to<br>strain from exercise or<br>normal household work<br>activities. And to be used for<br>the symptomatic relief and<br>management of chronic,<br>intractable pain and relief of<br>pain associated with arthritis.<br>EMS: The device is designed<br>to be used for stimulate | The OTC TENS/EMS<br>stimulator PulseRelief is<br>designed to be used for<br>temporary relief of pain<br>associated with sore and<br>aching muscles in the<br>shoulder, waist, back, neck,<br>upper extremities (arm) and<br>lower extremities (leg) due to<br>strain from exerciseor<br>normal household work<br>activities. It should be applied to<br>normal, healthy, dry and<br>clean skin of adult patients,<br>and is to be used for<br>stimulate healthy muscles in | To be used for<br>temporary relief of pain<br>associated with sore and<br>aching muscles due to<br>strain from exercise or<br>normal household and<br>work activities, It is also<br>intended for<br>symptomatic relief and<br>management of chronic,<br>intractable pain and<br>relief of pain associated<br>with arthritis | Compex® Sport<br>Plus is intended to<br>stimulate healthy<br>muscles in order to<br>improve or<br>facilitate muscle<br>performance. | Similar | 13 | Automatic Shut off | | Yes | Yes | Yes | Yes | Same | |
| | | | healthy muscles in order to<br>improve and facilitate muscle<br>performance. | order to improve<br>and facilitate muscle<br>performance. | muscle | | | 14 | User Override<br>Control? | | Yes<br>Power on/off button on the<br>device, and power on/off in<br>the APP software | Yes<br>Power on/off button on the<br>device, and power on/off in<br>the APP software | No | Power on/off button | SE<br>Note 2 |
| 5 | Power Source | | 3.7V battery supply | 3.7V battery supply | 3V battery supply | NIMH rechargeable<br>battery (4.8V≥<br>1200mA/h) (4cells<br>pack of 1.2V ) | SE<br>Note 1 | 15 | Indicator<br>Display: | On/Off<br>Status? | Yes | Yes | Yes | Yes | Same |
| | -Method of Line<br>current isolation | | N/A | N/A | N/A | N/A | Same | | | Low<br>Battery? | Yes | Yes | No | Yes | SE<br>Note 2 |
| | - Patient Leakage<br>Current (μΑ) | | | | | | SE<br>Note 1 | | | Voltage/Current<br>Level? | Yes | Yes | Active/inactive output | Yes | SE<br>Note 2 |
| | -Normal<br>condition<br>-Single fault<br>condition | | 0uA<br>2.0uA | <10uA<br><50uA | N/A | N/A<br>N/A | | 16 | Timer<br>(minutes) | | Range 1 ~ 59 minutes and<br>continuous | 1 ~ 59 minutes and<br>continuous | 30 minutes | 3-55.5min | SE<br>Note 2 |
| 6 | Average<br>current through<br>electrodes when<br>device is on but no<br>pulses are being<br>applied (μΑ) | DC | 0 | 0 | 0 | 0 | Same | 17 | Weight (grams.) | | 28grams (main device) | 62 grams (main device) | 20 grams | 350g | SE<br>Note 2 |
| 7 | Number of Output<br>Modes | | 2 (TENS/EMS(including<br>MASSAGE program)) | 2 (TENS/EMS) | 1 (TENS) | 9 modes/programs | SE<br>Note 2 | 18 | Dimensions (cm.)<br>H*W * L | | 13x41x67mm(main device) | 2 units, each 54x54x14<br>(excl electrodes) | 64x38x13[mm] | L142*W99*H36 | SE<br>Note 2 |
| 8 | Number<br>of<br>Output<br>Channel<br>S: | Synchro<br>nous or<br>Alternati<br>-ng? | N/A | N/A | N/A | Synchronous | SE<br>Note 2 | 19 | Housing Materials<br>& Construction | | PC + ABS | PC + ABS | Molded Plastic | / | SE<br>Note 3 |
| | Method<br>of<br>Channel<br>Isolation | | N/A | N/A | N/A | N/A | Same | | | | | | | | |
| 9 | Regulated Current | | Current control | Current control | Current control | Current control | Same | | | | | | | | |

#### Table 2: Substantial Equivalence Comparison Table

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## DONGDIXIN 厅灭

TECHNOLOGY CO., LTD.

### Table 3: Output Specification TENS mode

| | | Predicate device | | Remark | |
|----|---------------------------------------------------------------------|----------------------------------------|------------------------|-----------------------------------------------|-------------------|
| 1 | 510K# | K162479 | K151035 | K131159 | -- |
| 2 | Device Name | Smart Pain<br>Reliever<br>Mode: LT5019 | PulseRelief | SmartRelief | -- |
| 3 | Waveform | Biphasic | Biphasic | Asymmetrical<br>Biphasic | Similar<br>Note 4 |
| 4 | Shape | Rectangular | Rectangular | Rectangular | Same |
| 5 | Max Output Voltage (V) ±20% | -- | -- | -- | Similar<br>Note 5 |
| 6 | 500Ω | 31.2 | 31 | 30 | Similar<br>Note 5 |
| 7 | 2kΩ | 69.6 | 69 | 70 | -- |
| 8 | 10kΩ | 69.6 | 70 | 70 | -- |
| 9 | Pulse Duration (usec) | 150~250us | 60~350us | 30-220 $\mu$ s at<br>50% of peak<br>amplitude | Similar<br>Note 5 |
| 10 | Frequency (Hz) | 2~100Hz | 1~100Hz | 1~100Hz | Similar<br>Note 5 |
| 11 | Maximum Phase<br>Charge (uC) 500Ω | 30 | 1.6~6.8 | 13.2 | Similar<br>Note 5 |
| 12 | Maximum Current<br>Density 500Ω | 0.32mA/cm² | 0.002~0.045m<br>A /cm2 | 0.1mA/cm² | Similar<br>Note 5 |
| 13 | Maximum Average<br>Current (average<br>absolute value), mA,<br>500Ω | 1.2 | 0.06~1.36 | 2.06 | Similar<br>Note 5 |
| 14 | Maximum Average<br>Power Density,<br>(mW/cm²).500Ω | 1.9 | 0.24~1.69 | 1.5 | Similar<br>Note 5 |

#### Table 4: Output Specification EMS mode

| | | New device | Predicate device | Remark |
|----|-----------------------------------|-------------------------------------|--------------------|-------------------|
| 1 | 510K# | K162479 | K151035 | -- |
| 2 | Device Name or Program<br>Name | Smart Pain Reliever<br>Mode: LT5019 | PulseRelief | -- |
| 3 | Waveform | Biphasic | Biphasic | Same |
| 4 | Shape | Rectangular | Rectangular | Same |
| 5 | Max Output Voltage (V) ±20% | | | Similar |
| 6 | 500Ω | 31.2 | 31 | Note 5 |
| 7 | 2kΩ | 69.6 | 69 | |
| 8 | 10kΩ | 69.6 | 70 | |
| 9 | Pulse Duration (usec) | 200~370us | 150~350us | Similar<br>Note 5 |
| 10 | Frequency (Hz) | 3~75Hz | 40~65Hz | Similar<br>Note 5 |
| 11 | Maximum Phase Charge<br>(uC) 500Ω | 24 | 4.7~10.9 | Similar<br>Note 5 |
| 12 | Maximum Current Density | 0.248mA/cm2 | 0.019~0.037mA /cm2 | Similar |

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## DONGDIXIN

| TECHNOLOGY CO., LTD. | | | Version: 1.2 | |
|----------------------|------------------------------------------------------------|------|--------------|----------------|
| 500Ω | | | Note 5 | |
| 13 | Maximum Average Current (average absolute value), mA, 500Ω | 0.72 | 0.47~0.93 | Similar Note 5 |
| 14 | Maximum Average Power Density, (mW/cm2),500Ω | 1.2 | 0.62~1.15 | Similar Note 5 |

#### Table 5: Output Specification MASSAGE mode

| | | New device | Predicate device | Remark |
|----|-------------------------------------------------|-------------------------------------|-----------------------------------------|-------------------|
| 1 | 510K# | To be assigned | K083140 | -- |
| 2 | Device Name or Program Name | Smart Pain Reliever<br>Mode: LT5019 | Compex® Sport Plus<br>“MASSAGE” program | -- |
| 3 | Waveform | Biphasic | Biphasic | Same |
| 4 | Shape | Rectangular | Rectangular | Same |
| 5 | Max Output Voltage (V) ±20% | | | Similar |
| 6 | 500Ω | 31.2 | 60 | Note 5 |
| 7 | 2kΩ | 69.6 | 136 | |
| 8 | 10kΩ | 69.6 | 137 | |
| 9 | Pulse Duration (usec) | 250us | 200~400us | Similar<br>Note 5 |
| 10 | Frequency (Hz) | 10~80Hz | 2~100Hz | Similar<br>Note 5 |
| 11 | Maximum Phase Charge<br>(uC) 500Ω | 30 | 48 | Similar<br>Note 5 |
| 12 | Maximum Current Density<br>500Ω | 0.32mA/cm2 | Not available | Similar<br>Note 5 |
| 13 | Maximum Average Power<br>Density, (mW/cm2),500Ω | 1.9 | <12mW/cm2<br>(microwatt) @500Ω | Similar<br>Note 5 |

#### Comparison in Detail(s):

#### Note1:

Although the "Power Source(s)" and "Patient Leakage Current" of subject device are a little different from the predicate devices, they all comply with IEC 60601-1 requirements. So the differences will not raise any safety issue.

#### Note2:

Although the " Number of Output Modes" "Output Intensity Level", " Method of Channel Isolation", "Timer Range", "Weight" and "Dimensions" of subject device are different from the predicate devices, they are all comply with IEC 60601-1 and IEC 60601-2-10 requirements. So the differences of the function specifications will not raise any safety or effectiveness issue. Note

#### 3:

Although the "Housing Materials & Construction" of subject device is different from the predicate devices, they are all comply with ISO 10993-1, ISO 10993-5 and ISO 10993-10 requirements. So the differences of the Housing Materials & Construction will not raise any biological hazard.

#### Note4:

Although the "Waveform" of subject device is different from the predicate devices, the

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Image /page/12/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue and yellow. The text is in a sans-serif font. There are some Chinese characters to the right of the English text.

007 510 (k) Summary Version: 1.2

waveform is the key factors of the Net Charge (per pulse), and all the Net Charge (per pulse) are zero. The "Biphasic" waveform won't create Net Charge (per pulse), and not cause charge accumulation on the skin and cause burns. So the differences of the "Waveform" will not raise any safety or effectiveness issue.

#### Note5:

Although the "Maximum Output Voltage" . "Pulse Duration", "Maximum pulse frequency", . "Maximum Phase Charge", "Maximum Average Current", "Maximum Current Density", "Maximum Average Power Density of subject device", are a little different from the predicate devices, they all comply with the FDA guidance requirement for Transcutaneous Electrical Nerve Stimulator for Pain Relief and FDA guidance requirement for Powered Muscle Stimulator for Muscle Conditioning. So the differences of function specification will not raise any safety or effectiveness issue.

#### Performance Date: 6.

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

#### 6.1 Biocompatibility testing

The biocompatibility evaluation for the LT5019 was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process". As dictated by the application and duration of contact with the intact skin, the shell and electrode of testing included the following tests:

- Cytotoxicity
- · Sensitization
- Irritation

#### 6.2 Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the LT5019. The system complies with the IEC 60601-1, IEC 60601-1-6, IEC 60601-1-11 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC, and IEC 62133 for battery safety.

#### 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.

#### 6.4 Usability Testing

Usability testing according to IEC 62366, Applying Human Factors and Usability Engineering to Medical Device, was conducted.

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## DON

TECHNOLOGY CO., L

#### 7. Conclusions

The intended use and basic technological characteristics of the LT5019 device are equivalent with those of the referenced Predicate device K151035, K083140 and K131159.

The LT5019 device complies with the requirement of IEC60601-1, IEC 60601-2-10, IEC60601-1-2 and IEC60601-1-11. The bench testing and safety report documentation supplied in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness.

Moreover, the bench testing include the testing performed to characterize the waveform and stimulus parameters, and the performance testing proved that the ability of the LT5019 device to deliver a stimulus that meets design specifications.

In the other words, those engineering difference do not affect the intended use or alter the fundamental scientific technology of the device.

Thus, the Smart Pain Reliever device (K162479) is substantially equivalent to the predicate devices (K151035, K131159 and K083140).