Migraine Tens Digital Pain Reliever

K210364 · Shenzhen Dongdixin Technology Co., Ltd. · PCC · Jun 17, 2021 · Neurology

Device Facts

• Record ID: K210364
• Device Name: Migraine Tens Digital Pain Reliever
• Applicant: Shenzhen Dongdixin Technology Co., Ltd.
• Product Code: PCC · Neurology
• Decision Date: Jun 17, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5891
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The acute treatment of migraine with or without aura in patients 18 years of age or older. The prophylactic treatment of episodic migraine in patients 18 years of age or older.

Device Story

Neurostimulator for migraine management; applies electrical impulses to supratrochlearis and supraorbitalis nerves (V1 branch of trigeminal nerve) via forehead-mounted self-adhesive electrodes. Device operates via rechargeable battery; user selects stimulation programs via single-button interface; intensity adjustable during ramp-up. Intended for OTC use. Output signals (biphasic, rectangular, symmetrical) modulate nerve signaling to cerebral cortex to inhibit headache transmission. Benefits include non-pharmacological pain relief and migraine prophylaxis. Device consists of main unit, charging station, electrode pads, and USB cable.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility (ISO 10993-1: cytotoxicity, sensitization, irritation), electrical safety/EMC (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2), software verification/validation, output waveform verification via oscilloscope, and electrode impedance/current distribution testing.

Technological Characteristics

TENS neurostimulator; ABS+PC housing; rechargeable 3.7V LiPo battery. Biphasic, symmetrical, rectangular waveform. Fixed pulse width 250µs; frequencies 60Hz (prophylactic) and 100Hz (acute). Constant current output (max 16mA). Connectivity via USB for charging. Software-controlled with fixed programs. Standards: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, ISO 10993-1.

Indications for Use

Indicated for acute treatment of migraine with or without aura and prophylactic treatment of episodic migraine in patients 18 years of age or older.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator to treat headache is a device used to apply an electrical current to a patient's cranium through electrodes placed on the skin.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Appropriate analysis/testing must validate electromagnetic compatibility and electrical, mechanical, and thermal safety. (3) The technical parameters of the device, including waveform, output modes, maximum output voltage and current (with 500, 2,000, and 10,000 ohm loads), pulse duration, frequency, net charge (µC) per pulse, maximum phase charge at 500 ohms, maximum current density (mA/cm 2 , r.m.s.), maximum average current (mA), maximum average power density (W/cm2 ), and the type of impedance monitoring system must be fully characterized.(4) Electrical performance, adhesive integrity, shelf life, reusability, and current distribution testing of the electrodes must be conducted. (5) Appropriate software verification, validation, and hazard analysis must be performed. (6) Clinical performance data must demonstrate that the device is safe and effective as a treatment for headache in the indicated patient population. (7) Labeling must include the following: (i) Appropriate contraindications such as not for use in subjects with an implanted metallic or electronic device in the head, a cardiac pacemaker, or an implanted or wearable defibrillator. (ii) Appropriate warnings such as not to apply the device on the neck or chest, not to use the device in the presence of electronic monitoring equipment, not to use in the bath or shower, not to use while sleeping, not to use while driving, not to use while operating machinery. (iii) Appropriate precautions such as the long-term effects of chronic use of the device are unknown. (iv) A summary of the expected risks and benefits of using the device. (v) A summary of the clinical performance data, including information on the patient population for which the device has and has not been demonstrated to be effective, and any adverse events and complications. (vi) Information on how the device operates and the typical sensations experienced during treatment. (vii) A detailed summary of the device technical parameters. (viii) An expiration date/shelf life for the electrodes and the number of times they can be reused. (ix) Disposal instructions.

In combination with the general controls of the Food Drug & Cosmetic Act, the Transcutaneous Electrical Nerve Stimulator to Treat Headache is subject to the following special controls:

Predicate Devices

• Cefaly® Dual (K201895)

Submission Summary (Full Text)

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June 17, 2021

Shenzhen Dongdixin Technology Co., Ltd. Siping Yuan Floor 1-2, No.3 Building, Fanshen Xusheng Industrial Estate Xilixiaobaimang 518108 Nanshan District Shenzhen, Guangdong China

## Re: K210364

Trade/Device Name: Migraine TENS Digital Pain Reliever Regulation Number: 21 CFR 882.5891 Regulation Name: Transcutaneous electrical nerve stimulator to treat headache Regulatory Class: Class II Product Code: PCC Dated: February 3, 2021 Received: February 8, 2021

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. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 mediation-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 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

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## Indications for Use

510(k) Number (if known)

Device Name Migraine TENS Digital Pain Reliever Model: LT1103, LT1103-P

#### Indications for Use (Describe)

Migraine TENS Digital Pain Reliever LT1103

- The acute treatment of migraine with or without aura in patients 18 years of age or older.
- The prophylactic treatment of episodic migraine in patients 18 years of age or older.

Migraine TENS Digital Pain Reliever LT1103-P

- The prophylactic treatment of episodic migraine in patients 18 years of age or older.

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue and yellow. The word "DONGDIXIN" is in large, bold, blue letters, with a yellow "X" in the middle. Below the company name is the text "TECHNOLOGY CO., LTD." in a smaller font size.

# 510(k) SUMMARY

as required by section 21 CFR 807.92

Migraine TENS Digital Pain Reliever

| Date of Submission: | 05/28/2021 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Name: | Shenzhen Dongdixin Technology Co., Ltd. |
| Address: | Floor 1-2, No.3 Building, Fanshen Xusheng Industrial<br>Estate Xilixiaobaimang 518108 Nanshan District,<br>Shenzhen P. R. China |
| E-mail: | [e-mail] |
| Tel: | [phone] |
| FAX: | [phone] |
| Contact: | Siping Yuan |

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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 and yellow, with the company name in English and Chinese. The English name is in a sans-serif font, and the Chinese name is in a traditional font. The logo is simple and modern, and it conveys a sense of professionalism and innovation.

#### Proposed Device: 1.

Device Name: Migraine TENS Digital Pain Reliever

Model: LT1103, LT1103-P

Device classification Name: stimulator, nerve, electrical, transcutaneous, for migraine Regulation Description: Transcutaneous electrical nerve stimulator treat to headache. Regulation Medical Specialty: Neurology Neurology Review Panel: Regulation Number: 882.5891 Product Code: PCC Device Class: ll

#### 2. Predicate Device:

| Legally Marketed Device: | Cefaly® Dual |
|--------------------------|-------------------|
| 510(k) Number: | K201895 |
| Manufacturer: | CEFALY Technology |

#### Device Description: 3.

The Migraine TENS Digital Pain Reliever is a neurostimulator that is applied to the forehead using a self-adhesive electrode positioned bilaterally over the supratrochlearis and supraorbitalis nerves. Supratrochlearis and supraorbitalis (or supratrochlear and supraorbital) nerves belong to the upper branch of the trigeminal nerve (V1). The device uses electric impulses that are delivered to the supratrochlearis and supraorbitalis nerves to prevent and treat pain in the head area.

The Migraine TENS Digital Pain Reliever is operated by a rechargeable battery. Pressure on the single button allows selecting and starting a stimulation program, which runs automatically. And during ramping up, users could choose comfortable intensity level by pressing the button to lock up the current intensity.

The Migraine TENS Digital Pain Reliever consists of the following elements:

- Main Device
- Charging Station
- Electrode Pads
- USB cable

#### 4. Indications for Use:

Migraine TENS Digital Pain Reliever LT1103

- The acute treatment of migraine with or without aura in patients 18 years of age or older.
- The prophylactic treatment of episodic migraine in patients 18 years of age or older.

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Image /page/5/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue, with the exception of a yellow line that crosses through the "X" in "DIXIN". To the right of the English text is the company name in Chinese.

Migraine TENS Digital Pain Reliever LT1103-P

- The prophylactic treatment of episodic migraine in patients 18 years of age or older.

### 5. Comparison of Technological Characteristics with the Predicate Device

Both the subject and Predicate Device utilize the application of electrical current through electrodes placed on the forehead. By releasing the low frequency pulse with a particular frequency and reaching the advanced nerve center of cerebral cortex via nervus supraorbitalis, they can stop or postpone the transmission of headache signal to cerebral center.

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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, except for a yellow X in the middle of the word DONGDIXIN. To the right of the English text is the company name in Chinese.

### Basic technological characteristics, new device vs. Predicate device

| | | New device | New device | Predicate device | S.E. Discussion |
|----|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | 510K# | K210364 | K210364 | K201895 | N/A |
| 2 | Device Name and<br>Model | Migraine TENS Digital Pain<br>Reliever<br>Model: LT1103 | Migraine TENS Digital Pain<br>Reliever<br>Model: LT1103-P | Cefaly® Dual | N/A |
| 3 | Manufacturer | Shenzhen Dongdixin<br>Technology Co., Ltd. | Shenzhen Dongdixin<br>Technology Co., Ltd. | CEFALY Technology | N/A |
| 4 | Intended for use | The acute treatment of<br>migraine with or without<br>aura in patients 18 years of<br>age or older.<br>The prophylactic treatment<br>of episodic migraine in<br>patients 18 years of age or<br>older. | The prophylactic treatment<br>of episodic migraine in<br>patients 18 years of age or<br>older. | The acute treatment of<br>migraine with or without<br>aura in patients 18 years<br>of age or older.<br>The prophylactic<br>treatment of episodic<br>migraine in patients 18<br>years of age or older. | Equivalent<br>The intended for use of<br>LT1103 is equivalent with<br>predicate device, the<br>intended for use of<br>LT1103-P is covered by<br>the predicate device<br>because LT1103-P<br>contains only one<br>program for prophylactic<br>treatment. |
| 5 | Where used | OTC | OTC | OTC | Equivalent |
| 6 | Power Source | 1 rechargeable LiPo 3.7 V<br>battery | 1 rechargeable LiPo 3.7 V<br>battery | 1 rechargeable LiPo 3.7 V<br>battery | Equivalent |
| | -Method of Line<br>current isolation | N/A, battery powered | N/A, battery powered | N/A, battery powered | Equivalent |
| | - Patient Leakage<br>Current (μΑ)<br>-Normal condition<br>-Single fault condition | N/A, battery powered | N/A, battery powered | N/A, battery powered | Equivalent |
| 7 | Channels | 1 | 1 | 1 | Equivalent |
| | Synchronous or<br>Alternating? | N/A | N/A | N/A | Equivalent |
| | Method of Channel<br>Isolation | N/A | N/A | N/A | Equivalent |
| 8 | Constant Current? | Yes | Yes | Yes | Equivalent |
| | Constant Voltage? | No | No | No | |
| 9 | Software/Firmware/M<br>icro processor<br>Control? | Yes<br>2 fixed programs:<br>-1 fixed program for the<br>treatment of migraine<br>attacks(Program 1)<br>-1 fixed program for<br>prophylactic treatment of<br>migraine attacks(Program 2) | Yes<br>1 fixed program:<br>-1 fixed program for<br>prophylactic treatment of<br>migraine attacks | Yes<br>2 fixed programs:<br>-1 fixed program for the<br>acute treatment of<br>migraine attacks(Program<br>1)<br>-1 fixed program for<br>prophylactic treatment of<br>migraine attacks(Program<br>2) | Equivalent, LT1103 is<br>equivalent with predicate<br>device.<br>LT1103-P has only one<br>program, which is covered<br>by the predicate device. |
| | Program 1:<br>Max. output current<br>Pulse width<br>Pulse frequency<br>Session duration | 16 mA<br>250 $\mu$ s,<br>fixed 100 Hz,<br>fixed 60 minutes | N/A | 16 mA<br>250 $\mu$ s,<br>fixed 100 Hz,<br>fixed 60 minutes | Equivalent<br>The program 1 of LT1103<br>is equivalent with<br>predicate device, while<br>LT1103-P does not have<br>program 1. |
| | Program 2:<br>Max. output current<br>Pulse width<br>Pulse frequency<br>Session duration | 16 mA<br>250 $\mu$ s,<br>fixed 60 Hz,<br>fixed 20 minutes | 16 mA<br>250 $\mu$ s,<br>fixed 60 Hz,<br>fixed 20 minutes | 16 mA<br>250 $\mu$ s,<br>fixed 60 Hz,<br>fixed 20 minutes | Equivalent |
| 10 | Timer Range (minutes) | 20 minutes, 60 minutes | 20 minutes | 20 minutes, 60 minutes | Equivalent |
| 11 | Weight (grams.) | 14 | 14 | 12 | Different, but the subject<br>device has passed the<br>testing according to the<br>requirement of<br>IEC60601-1. |
| 12 | Dimensions (mm)<br>H*W * L | 41 mm x 41 mm x 13.4mm | 41 mm x 41 mm x 13.4mm | 55 mm x 40 mm x 15mm | |
| 13 | Housing Materials &<br>Construction | ABS+PC for Main device<br>ABS for Charging station | ABS+PC for Main device<br>ABS for Charging station | Plastic ABS | requirement of<br>IEC60601-1.<br>The difference does not |
| | | | | | raise any safety or<br>effectiveness issue. |
| 14 | Waveform | Biphasic | Biphasic | Biphasic | Equivalent |
| 15 | Shape | Rectangular<br>Full compensated<br>Symmetrical | Rectangular<br>Full compensated<br>Symmetrical | Rectangular<br>Full compensated<br>Symmetrical | Equivalent |
| 16 | Max Output Voltage (V) ±20% | | | | |
| 17 | 500Ω | 8 | 8 | 8 | Equivalent |
| 18 | 2kΩ | 32 | 32 | 32 | |
| 19 | 10kΩ | 60 | 60 | 60 | |
| 20 | Max Output Current (mA) ±20% | | | | |
| 21 | 500Ω | 16 | 16 | 16 | Equivalent |
| 22 | 2kΩ | 16 | 16 | 16 | |
| 23 | 10kΩ | 6 | 6 | 6 | |
| 24 | Pulse Width(usec) | 250 µs, fixed | 250 µs, fixed | 250 µs, fixed | Equivalent |
| 25 | Frequency (Hz) | 60 Hz, fixed<br>100 Hz, fixed | 60 Hz, fixed | 60 Hz, fixed<br>100 Hz, fixed | Equivalent, the<br>frequency of LT1103 is<br>equivalent with<br>predicate device.<br>LT1103-P has only one<br>program, which is<br>covered by the predicate<br>device. |
| 26 | Maximum Current<br>Density<br>(mA/cm²,500Ω) | 2.37 | 2.37 | 2.37 | Equivalent |
| 27 | Maximum Average<br>Power Density,<br>(W/cm²),500Ω | 0.000047 | 0.000017 | 0.000047 | Equivalent, the<br>Maximum Average<br>Power Density of LT1103<br>is equivalent with<br>predicate device.<br>IT1103-P has only one |

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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, except for a stylized "X" in the middle, which is in yellow. To the right of the logo are three Chinese characters in blue.

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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 "TECHNOLOGY CO., LTD." is in a smaller font size than "DONGDIXIN". There are also three Chinese characters to the right of the English text.

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Image /page/9/Picture/0 description: The image contains 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 with an orange line. To the right of the English name is the company name in Chinese characters. The text is dark blue, except for the orange line in the "X".

| | | | program, which is<br>covered by the predicate |
|--|--|--|-----------------------------------------------|
| | | | device. |

#### 6. Performance Data:

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

#### 6.1 Biocompatibility testing

The biocompatibility evaluation for the subject device was conducted in accordance with the International Standard ISO 1099-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process". As dictation of contact with the intact skin, the 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 system complies with the IEC 60601-111 and EC 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 as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device was considered as a "Moderate" level of concern.

#### 6.4 Output waveform Testing

For each program, occilloscope tracing diagrams describing the electrical output was provided to verify the output specifications of the device according to IEC 60601-2-10.

#### 6.5 Electrode impedance and current distribution testing.

Electrode impedance and current distribution testing were conducted on the electrode.

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Image /page/10/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue, except for a yellow X in the middle of the word DONGDIXIN. To the right of the English text is the company name in Chinese.

## 7. Conclusions

The intended use and basic technological characteristics of the Migraine TENS Digital Pain Reliever LT1103, LT1103-P are significantly equivalent with those of the Predicate device K201895. Any technological differences do not raise new questions regarding safety and effectiveness.