Smart Neck Stimulator

K200558 · Guandong Skg Intelligent Technology Co., Ltd. · NUH · Oct 4, 2021 · Neurology

Device Facts

• Record ID: K200558
• Device Name: Smart Neck Stimulator
• Applicant: Guandong Skg Intelligent Technology Co., Ltd.
• Product Code: NUH · Neurology
• Decision Date: Oct 4, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Smart Neck Stimulator is designed to be used to temporarily relieve pain associated with sore and aching muscles in the back of neck due to strain from exercise or normal household work activities.

Device Story

Smart Neck Stimulator is a wearable TENS device for neck pain relief. It features a streamlined, ring-shaped design worn around the neck. The device delivers electrical pulses via stainless steel electrode pads to the skin and provides a warming sensation (37°C to 41°C). It is operated by a radiofrequency remote control with buttons for mode selection (3 modes), intensity adjustment (15 levels), and heating control (on/off). The device is powered by a 3.7V 1500mAh lithium battery. It is intended for OTC use by individuals experiencing muscle strain. The device includes automatic shut-off and no-load trip safety features. By providing electrical stimulation and heat, it aims to alleviate muscle soreness and aching, assisting in pain management for the user.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and performance were validated through testing against standards including IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, IEC 62133-2, IEC 62366-1, ISO 10993-5, and ISO 10993-10.

Technological Characteristics

Materials: PC and ABS plastic housing, stainless steel electrode pads. Energy: 3.7V 1500mAh lithium battery. Principle: Transcutaneous Electrical Nerve Stimulation (TENS) with integrated heating (37-41°C). Form factor: Streamlined ring design for neck. Connectivity: RF remote control. Safety: Type BF applied part, automatic shut-off, automatic no-load trip. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, IEC 62133-2, IEC 62366-1, ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for temporary relief of pain associated with sore and aching muscles in the back of the neck due to strain from exercise or normal household work activities. Intended for OTC use.

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

• HIVOX OTC Electrical Stimulator (K171803)
• Neck Care Therapy (K172897)

Submission Summary (Full Text)

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October 4, 2021

Guandong Skg Intelligent Technology Co., Ltd Fanny Yuan Manager No.1, 7/F. Yingfeng Business Center, No.8 Yixing Road, Beijiao Town Shunde District, Foshan City, Guandong Province 528303 China

Re: K200558

Trade/Device Name: Smart Neck Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: August 26, 2021 Received: September 1, 2021

Dear Fanny 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 (OS) 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,

For Pamela Scott 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) K200558

Device Name Smart Neck Stimulator (Model: 4098 (RED))

Indications for Use (Describe)

The Smart Neck Stimulator is designed to temporarily relieve pain associated with sore and aching muscles in the back of neck due to strain from exercise or normal household work activities.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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### 510(k) Summary of K200558

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

#### Submitter's Information 1.

- � Company Name: GUANGDONG SKG INTELLIGENT TECHNOLOGY CO., LTD
- Establishment Registration Number: Applying �
- Address: No.1, 7/F, Yingfeng Business Center, No.8 Yixing Road, Beijiao Town, Shunde District, � Foshan City, Guangdong Province, China
- � Postal Code: 528303
- � Phone: [phone]
- � TEL: [phone]
- Contact Person (including title): Mao Hui Zhang (Certificated Engineer) �
- E-mail: [e-mail] �

#### 2. Manufacturer

- Company Name: Guangdong Shiqi Manufacture Co., Ltd �
- � Address: D10-11, Lunjiao Intensive Industrial Zone, Licun Village Committee, Lunjiao Street Office, Shunde District, Foshan City, Guangdong Province, China
- Phone: [phone] �
- � Tel: [phone]
- Contact Person: Mao Hui Zhang �

#### 3. Application Correspondent:

- � Company: Share Info (Guangzhou) Medical Consultant Ltd.
- � Contact Name: Ms. Fanny Yuan
- E-mail: [e-mail] �

#### 4. Subject Device Information

- Smart Neck Stimulator � Trade Name:
- Transcutaneous Electrical Nerve Stimulator for Pain Relief Common Name: �
- Stimulator, nerve, transcutaneous, over-the-counter � Classification name:
- Neurology, Physical Medicine Review Panel: �
- NUH Product Code: �
- ll � Regulation Class:
- 882.5890 Regulation Number: �

#### 5. Predicate Device Information

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| Sponsor | HIVOX BIOTEK INC. | Shenzhen OSTO Technology Co.,<br>Ltd. |
|--------------------------|---------------------------------|---------------------------------------|
| Device Name and<br>Model | HIVOX OTC Electrical Stimulator | Neck Care Therapy |
| 510(k) Number | K171803 | K172897 |
| Product Code | NUH, NGX | NUH, NGX |
| Regulation Number | 882.5890, 890.5850 | 882.5890, 890.5850 |
| Regulation Class | II | II |

## 6. Device Description

The subject device is intended to use on back of neck and it designed accord with human body cervical physiological curvature of streamlined ring design.

The device totally has 3 modes and each mode has 15 output Intensity Levels, so the device can give certain electrical pulse through the electrode pads on the skin to help users to enjoy back neck stimulation. It can also provide a constant temperature of 37°C to 41°C to provide a warming sensation. The subject device can be controlled by a remote control which based on the radiofrequency technology. There are 5 buttons in the remote control, the "M" button for modes selection, "+" or "-" button for intensity

selected to increase or decrease, the " "" button intends to turn the heating function on and the " Ho button intends to turn the heating function off.

The device can be turned on when both power button on subject device has been turned on and the treatment mode can be selected by the remote control.

## 7. Intended Use / Indications for Use

The Smart Neck Stimulator is designed to be used to temporarily relieve pain associated with sore and aching muscles in the back of neck due to strain from exercise or normal household work activities.

### 8. Test Summary

Smart Neck Stimulator has been evaluated the safety and performance by lab bench testing as following:

| Standards No. | Standard Title | Version | Date |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------|
| IEC 60601-1 | Medical Electrical Equipment - Part 1:<br>General Requirements For Basic Safety<br>And Essential Performance | 2005/(R)2012 And<br>A1:2012, | 07/09/2014 |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2:<br>General requirements for basic safety<br>and essential performance - Collateral<br>standard: Electromagnetic compatibility<br>- Requirements and tests | Edition 4.0 2014-02 | 09/17/2018 |
| IEC 60601-2-10 | Medical Electrical Equipment - Part 2-<br>10: Particular Requirements For The<br>Basic Safety And Essential<br>Performance Of Nerve And Muscle<br>Stimulators | Edition 2.1 2016-04 | 06/07/2018 |

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| Standards No. | Standard Title | Version | Date |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|------------|
| IEC 60601-1-11 | Medical electrical equipment - Part 1-11:<br>General requirements for basic safety<br>and essential performance - Collateral<br>Standard: Requirements for medical<br>electrical equipment and medical<br>electrical systems used in the home<br>healthcare environment | Edition 2.0 2015-01 | 06/27/2016 |
| IEC 62133-2 | Secondary Cells And Batteries<br>Containing Alkaline Or Other Non-Acid<br>Electrolytes - Safety Requirements For<br>Portable Sealed Secondary Cells, And<br>For Batteries Made From Them, For<br>Use In Portable Applications - Part 2:<br>Lithium Systems | Edition 1.0 2017-02 | 01/14/2019 |
| IEC 62366-1 | Medical Devices - Part 1: Application Of<br>Usability Engineering To Medical<br>Devices | Edition 1.0 2015-02 | 12/23/2016 |
| ISO 10993-5 | Biological evaluation of medical devices<br>- Part 5: Tests for In Vitro cytotoxicity | Third Edition 2009-06-01 | 12/23/2016 |
| ISO 10993-10 | Biological evaluation of medical devices<br>- Part 10: Tests for irritation and skin<br>sensitization | Third Edition 2010-08-01 | 07/26/2016 |

## 9. Comparison to predicate device and conclusion

The Smart Neck Stimulator has similar intended use, technological characteristics and same principle of operation as these predicate devices. Although there are several specifications different between these devices, the comparison analysis has been completed to demonstrate that the differences between these parameters would not adversely impact the safety and effectiveness of the subject device has undergone safety and performance tests, and the results complied with the test requests. Therefore the differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | |
|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|--------|
| Company | GUANGDONG SKG<br>INTELLIGENT<br>TECHNOLOGY CO., LTD | HIVOX BIOTEK INC. | Shenzhen OSTO<br>Technology Co., Ltd. | -- | |
| Trade Name | Smart Neck Stimulator | HIVOX OTC Electrical<br>Stimulator | Neck Care Therapy | -- | |
| Classification<br>Name | Stimulator, nerve,<br>transcutaneous, over-the-<br>counter | Stimulator, nerve,<br>transcutaneous, over-<br>the-counter | Stimulator, nerve,<br>transcutaneous, over-<br>the-counter,<br>Stimulator, Muscle,<br>Powered, For Muscle<br>Conditioning | -- | |
| 510(k) Number | K200558 | K171803 | K172897 | -- | |
| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | |
| Product Code | NUH | NUH, NGX | NUH, NGX | SE | |
| Intended Use /<br>Indications for<br>Use | The Smart Neck<br>Stimulator is designed to<br>be used to temporarily<br>relieve pain associated<br>with sore and aching<br>muscles in the back of<br>neck due to strain from<br>exercise or normal<br>household work activities. | HIVOX OTC Electrical<br>Stimulator, SEM44:<br>TENS: The device is<br>designed to be used<br>for temporary relief of<br>pain associated with<br>sore and aching<br>muscles in the<br>shoulder, waist, back,<br>neck, upper<br>extremities (arm),<br>lower extremities<br>(leg), abdomen and<br>bottom due to strain<br>from exercise or<br>normal household<br>work activities.<br>EMS: The device is<br>designed to be used<br>for stimulate healthy<br>muscles in order to<br>improve and facilitate<br>muscle performance.<br>HIVOX OTC Electrical<br>Stimulator, SEM44-1:<br>TENS: The device is<br>designed to be used<br>for temporary relief of<br>pain associated with<br>sore and aching<br>muscles in the<br>shoulder, waist, back,<br>neck, upper<br>extremities (arm),<br>lower extremities<br>(leg), abdomen and<br>bottom due to strain<br>from exercise or<br>normal household<br>work activities. | To be used for<br>temporary relief of<br>pain associated with<br>sore and aching<br>muscles in the<br>shoulder, waist, back<br>of neck, back, arm,<br>and leg, due to strain<br>from exercise or<br>normal household<br>and work activities.<br>- Neck Pad is<br>used in back of neck.<br>- Meridian Pad<br>is used in shoulder,<br>waist, back, and arm. | SE | |
| Type of use | OTC | OTC | OTC | SE | |
| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | |
| Power source | 3.7V, 1500mAh lithium<br>battery | 4.5V (batteries,<br>3x1.5V AAA) | For the power<br>adaptor:<br>Input: 100~240Vac<br>50/60Hz, 0.2A;<br>Output: 5Vdc, 1A<br>Unit Input: 5Vdc, 1A<br>For Battery: 3.7 Vdc,<br>500mAh<br>For Remote Control:<br>(2x1.5V AAA battery) | SE | |
| Method of Line<br>Current<br>Isolation | Type BF Applied Part | Not publicly available | Type BF Applied Part | SE | |
| Patient<br>Leakage<br>Current | NC | 50 μΑ | Not publicly available | AC: 54.5μΑ<br>DC: 0.5µA | SE |
| | SFC | 100 μΑ | Not publicly available | AC: 120μA<br>DC: 0.6μA | Note 2 |
| Average<br>current through<br>electrodes<br>when device is<br>on but no<br>pulses are<br>being applied | <10μΑ | 0 | <0.01μA | SE<br>Note 2 | |
| Number of<br>Output Modes | 3 | TENS: 15<br>EMS: 35 | 2 | SE | |
| Heating Setting | On and off | Not publicly available | Not publicly available | SE<br>Note 2 | |
| Heating<br>temperature | 37-41°C | Not publicly available | Not publicly available | SE<br>Note 2 | |
| Output<br>Intensity Level | 15 steps | Not publicly available | 50 steps | SE<br>Note 2 | |
| Number of<br>Output<br>Channels | 1 | 2 | Not publicly available | SE<br>Note 2 | |
| Synchronous<br>or Alternating? | Synchronous | Synchronous | Synchronous | SE | |
| Regulated<br>Voltage or<br>Current ? | Regulated voltage | Regulated voltage | Voltage Control | SE | |
| Software /<br>Firmware /<br>Microprocessor<br>Control? | Yes | Yes | Yes | SE | |
| Automatic<br>Overload Trip | No | Yes | No | SE | |
| Automatic No-<br>Load Trip | Yes | Yes | No | SE | |
| Automatic Shut<br>Off | Yes | Yes | Yes | SE | |
| User Override | Yes | Yes | Yes | SE | |
| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | |
| Control | | | | | |
| Timer Range<br>(minutes) | 15 min | 5-100 min | 5-30 min | SE<br>Note 2 | |
| Weight | Main Unit: 200g | 89 g (including belt<br>clip, without batteries),<br>123 g (including belt<br>clip and batteries) | Main Unit: 222g | SE<br>Note 1 | |
| Dimensions | Main Unit: 141.4 mm x<br>137.9 mm x 46 mm | 132 x 63 x 29.5 mm<br>(including belt clip) | Main Unit:<br>187.2*169*67.3 mm | SE<br>Note 1 | |
| Pad dimension | 44.2 mm x 29.8 mm | 20.25 sqcm x4 (81<br>sqcm) | 8.9 cm *5.8 cm | SE<br>Note 1 | |
| Housing unit | PC, ABS plastic | ABS | ABS plastic | SE | |
| Electrode pad<br>material | Stainless steel | Not publicly available | Stainless steel | SE | |
| Waveform | Pulsed, symmetric,<br>biphasic | Biphasic | Pulsed, symmetric,<br>biphasic | SE | |
| Shape | Rectangular, with<br>interphase interval | Square | Rectangular, with<br>interphase interval | SE | |
| Maximum<br>Output Voltage | 76V±10% @500Ω<br>106V±10% @2KΩ<br>138V±10% @10KΩ | 100V±10%@500Ω<br>180V±10% @2KΩ<br>250V±10% @10KΩ | 44V±10% @500Ω<br>80V±10% @2KΩ<br>112V±10% @10KΩ | SE<br>Note 2 | |
| Maximum<br>Output Current | 152mA±10% @500Ω<br>54mA±10% @2KΩ<br>13.8mA±10% @10KΩ | 200mA±10% @500Ω<br>90mA±10% @2KΩ<br>25mA±10% @10KΩ | 88mA±10% @500Ω<br>44mA±10% @2KΩ<br>11.2mA±10%<br>@10KΩ | SE<br>Note 2 | |
| Pulse Duration<br>(μs) | Mode 1: 40μs<br>Mode 2: 200µs<br>Mode 3: 150µs | 50-450μs | 120μs…