XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV)

K172887 · Guangzhou Xinbo Electronic Co., Ltd. · GXY · Apr 19, 2018 · Neurology

Device Facts

• Record ID: K172887
• Device Name: XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV)
• Applicant: Guangzhou Xinbo Electronic Co., Ltd.
• Product Code: GXY · Neurology
• Decision Date: Apr 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

XinBo Electrodes (Models: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) are cutaneous electrodes to be used with legally marketed TENS stimulating devices for which stimulation of the back of the neck and upper back is appropriate. They will deliver the stimulation signals generated by the stimulator to the back of the neck, upper back and shoulder surface areas with which they are in contact.

Device Story

Cutaneous electrodes designed for use with external TENS stimulators; deliver electrical stimulation signals to back of neck, upper back, and shoulder areas. Device consists of conductive pads (silver-plated nylon or conductive silicone rubber) that interface with skin; connects to stimulator via lead wires with snap/socket connectors. Used in home or clinical settings by patients or providers. Low resistance (<7 ohms/inch) ensures uniform current distribution. Benefits include targeted pain relief via TENS therapy. No active electronic components; passive interface device.

Clinical Evidence

Bench testing only. Includes biocompatibility (ISO 10993-5, ISO 10993-10), electrical safety (IEC 60601-1), hot spot verification, and usability study (IEC 60601-1-6, IEC 62366). No clinical data presented.

Technological Characteristics

Materials: Silver-plated nylon (silver fiber knitted fabric), cotton (crystal super cashmere, mutispandex), conductive silicone rubber, PU foam. Impedance: <7 ohms/inch. Connectivity: Lead wires with female socket or male snap connectors. Standards: ISO 10993-5/10, IEC 60601-1, IEC 60601-1-6, IEC 62366.

Indications for Use

Indicated for use with legally marketed TENS stimulating devices to deliver electrical stimulation to the back of the neck, upper back, and shoulder surface areas.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Predicate Devices

• Theraknit Garments (K053214)
• Dr-Ho's Foot Pad Electrode (K151693)
• AMPCARE 50709 Series Electrodes (K121483)

Submission Summary (Full Text)

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April 19, 2018

Guangzhou Xinbo Electronic Co., Ltd. % Ms. Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, Guandong, 510006 Cn

Re: K172887

Trade/Device Name: XinBo Electrode (Model: Neck Therapy Pro - I. Neck Therapy Pro - II. Neck Therapy Pro - III, Neck Therapy Pro - IV) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: January 14, 2018 Received: January 19, 2018

Dear Ms. Cassie Lee:

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.

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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 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 (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.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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

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# Indications for Use

510(k) Number (if known) K172887

Device Name XinBo Electrodes

#### Indications for Use (Describe)

XinBo Electrodes (Model: Neck Therapy Pro - II; Neck Therapy Pro - II; Neck Therapy Pro - III, Neck Therapy Pro - IV) are cutaneous electrodes to be used with legally marketed TENS stimulating devices for which stimulation of the back of the neck and upper back is appropriate. They will deliver the stimulation signals generated by the back of the neck, upper back and shoulder surface areas with which they are in contact.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|----------------------------------------------------------|
| | Indoor Use (Applicable to OFF!® Insect Repellents Only) |
| | Outdoor Use (Applicable to OFF!® Insect Repellents Only) |

| | 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

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

# 1. Submitter's Information

510(k) Owner's Name: Guangzhou Xinbo Electronic Co., Ltd. Establishment Registration Number: K172887 Address: 2nd Building, Juntuo Industry Park, XinqyeDadao, Nancun Town, Panyu District, Guangzhou City, Guangdong Province, China Contact Person: Li Huifang (Manager) Email: [e-mail]

#### Application Correspondent:

Contact Person: Ms. Cecilia Ceng / Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China Tel: [phone] Email: [e-mail]

# 2. Subject Device Information

Trade Name: XinBo Electrodes Common Name: Cutaneous Electrode Review Panel: Neurology Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV Regulation Number: 882.1320

# 3. Predicate Device Information

| Sponsor | Neurotron Medical, Inc | DRTV Asia Ltd. | AMPCAXE, LLC |
|----------------------|------------------------|-------------------------------|------------------------------------|
| Device Name | Theraknit Garments | Dr-Ho's Foot Pad<br>Electrode | AMPCARE 50709<br>Series Electrodes |
| 510(k) Number | K053214 | K151693 | K121483 |
| Product Code | GXY | GXY | GXY |
| Regulation<br>Number | 882.1320 | 882.1320 | 882.1320 |
| Regulation Class | II | II | II |

#### 4. Device Description

The electrodes can be use together with any legally marketed TENS stimulating devices for which stimulation of the back of the neck and upper back is appropriate. For the silver coated Nylon yarn electrodes, they can be used dry or wet when in contact with the skin. The entire surface of each

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electrodes is very conductive having a resistance of less than 7 ohms per inch; For the model "Neck Therapy Pro - III", conductive silicone rubber having a resistance of less than 7 ohms per inch, these low resistance provides low current density with uniform current distribution.

#### 5. Intended Use / Indications for Use

XinBo Electrodes (Models: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) are cutaneous electrodes to be used with legally marketed TENS stimulating devices for which stimulation of the back of the neck and upper back is appropriate. They will deliver the stimulation signals generated by the stimulator to the back of the neck, upper back and shoulder surface areas with which they are in contact.

#### 6. Test Summary

XinBo Electrodes have been evaluated the safety and performance by lab bench testing as following:

- Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards �
- The electrode wire is compliance with 21 CFR 898 by IEC 60601-1 (version 3.1, clause 8.5.2.3) � evaluation.
- � Performance test (hot spots verification test) according to manufacturer self-requirements.
- � Usability study according to IEC 60601-1-6, IEC 62366, and "FDA Guidance for Applying Human Factors and Usability Enqineering to Medical Devices"

# 7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, and intended use of subject device are substantially equivalent to the predicate devices.

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 | Predicate Device 3 | Remark |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Device Name<br>and Model | XinBo Electrodes<br>(Models: Neck<br>Therapy Pro - I, Neck<br>Therapy Pro - II, Neck<br>Therapy Pro - III, Neck<br>Therapy Pro - IV) | Theraknit Garments | Dr-Ho's Foot Pad<br>Electrode | AMPCARE 50709<br>Series Electrodes | -- |
| 510(k) Number | K172887 | K053214 | K151693 | K121483 | -- |
| Product Code | GXY | GXY | GXY | GXY | SE |
| OTC or Rx-<br>only | OTC | Rx-only | OTC | Rx-only | SE |
| Intended Use /<br>Indications for<br>Use | XinBo Electrodes<br>(Models: Neck<br>Therapy Pro - I, Neck<br>Therapy Pro - II, Neck<br>Therapy Pro - III, Neck<br>Therapy Pro - IV) are<br>cutaneous electrodes | The TheraKnit<br>Garment Electrodes<br>are cutaneous<br>electrodes to be used<br>with legally marketed<br>TENS stimulating<br>device. The knitted | The Cutaneous<br>Electrodes, "Dr-Ho's<br>Foot Pad Electrodes",<br>are intended to be<br>used with legally<br>marketed electrical<br>stimulating devices | AMPCA RE 50709<br>Series of cutaneous<br>electrodes are<br>intended to be used to<br>apply electrical<br>stimulation current to<br>the patient's skin. | SE |
| to be used with legally<br>marketed TENS<br>stimulating devices for<br>which stimulation of<br>the back of the neck<br>and upper back is<br>appropriate. They will<br>deliver the stimulation<br>signals generated by<br>the stimulator to the<br>back of the neck,<br>upper back and<br>shoulder surface<br>areas with which they<br>are in contact. | garment electrodes<br>will deliver the<br>stimulation signals<br>generated by the<br>stimulator to the body<br>surface with which<br>they are in contact.<br>These body parts can<br>include hand (glove),<br>feet (socks), elbow or<br>knee (sleeve), arm,<br>leg, shoulder, back<br>(pads). | such as<br>transcutaneous<br>electrical nerve<br>stimulators or<br>powered muscle<br>stimulators. The<br>cutaneous electrodes<br>will deliver the<br>stimulation signals<br>generated by the<br>stimulator to the<br>bottom of the feet<br>which they are in<br>contact with. | Example electrical<br>stimulation current<br>applications of these<br>electrodes are:<br>a) Transcutaneous<br>Electrical Nerve<br>Stimulation (TENS)<br>for pain relief<br>b) Electrical muscle<br>stimulation (EMS) for<br>neck muscle<br>stimulation.<br>c) Functional<br>electrical stimulation<br>(FES)<br>d) Galvanic<br>stimulation<br>e) Microcurrent<br>electrical nerve<br>stimulation (MENS)<br>J) Interferential (IF)<br>stimulation<br>g) Neuromuscular<br>electrical stimulation<br>(NMES), including for<br>muscle re-education<br>by application of<br>external stimulation to<br>the muscles<br>necessary for<br>pharyngeal<br>contraction. | | |
| Body Parts to<br>Use on | Back of the neck,<br>upper back and<br>shoulder | Hand, feet, elbow or<br>knee, arm, leg,<br>shoulder, back | Bottom of the feet | Back of the neck | SE |
| Design<br>(Shape) | Model A: Neck<br>Therapy Pro - I<br>Model B: Neck<br>Therapy Pro - II<br>Model C: Neck<br>Therapy Pro - III<br>Model D: Neck<br>Therapy Pro - IV | Electrode A: Glove<br>Style<br>Electrode B: Socks<br>Style<br>Electrode C: Sleeve<br>Style<br>Electrode D: Pads<br>Style | Electrode A: foot-shaped Electrode | | SE<br>Note 1 |
| Dimensions | Model A:<br>For the whole product:<br>260 x 297.8 mm<br>For only the electronic<br>pads part: 4<br>electrodes on each<br>models, two of them<br>are: 65 mm in<br>diameter, the other<br>two of them are<br>irregularly: 75 mm in<br>diameter and about<br>105 mm long<br>Model B:<br>For the whole product: | | | | SE<br>Note 1 |
| | | | | | |
| | 208 x115 x110 mm<br>For only the electronic<br>pads part: 2<br>electrodes on each<br>models, each<br>electrode is: 50 mm in<br>diameter<br>Model C:<br>For the whole product:<br>264.2 x 298.5 mm<br>For each the<br>electronic pads part: 6<br>electrodes on each<br>models, each<br>electrode is: 48 x26.2<br>mm²<br>Model D:<br>For the whole product:<br>300x 450 x 110mm<br>For each electronic<br>pads part: 4<br>electrodes on each<br>models, each<br>electrode is: 45 mm in<br>diameter | | | | |
| Impedance | For Model A: 7 ohms | 7 ohms resistance per inch | <7 ohms per inch | <7 ohms per inch | SE |
| Parameters | per inch<br>For Model B: 7 ohms<br>per inch<br>For Model C: Less<br>than 7 ohms per inch<br>For Model D: 7 ohms<br>resistance per inch | | | | |
| Patient<br>Contacting<br>Material | For Model A: Silver<br>plated nylon (Silver<br>Fibre Knitted Fabric),<br>cotton (Crystal Super<br>Cashmere)<br>For Electrode B: Silver<br>plated nylon (Silver<br>Fibre Knitted Fabric),<br>cotton (Crystal Super<br>Cashmere and<br>Mutispandex)<br>For Electrode C:<br>Conductive silicone<br>rubber, PU Foam<br>For Electrode D: Silver<br>plated nylon (Silver<br>Fibre Knitted Fabric),<br>cotton (Crystal Super<br>Cashmere) | Silver plated nylon | Conductive silicone<br>rubber | -- | SE<br>Note 1 |
| Lead Wire | Lead wire with female | Lead wire with female | Connector Lead wire | -- | SE |
| Type and | socket, or snap button | socket, or snap button | .080" female socket | | |
| Characteristics | with male snap connector | with male snap connector | connector | | |
| Operating<br>Environment | Temperature: 5~40°C<br>Humidity: ≤ 80%RH<br>Atmospheric Pressure:<br>86~106kPa | Temperature: 5~40°C<br>Humidity: ≤ 80%RH<br>Atmospheric<br>Pressure: 86~106kPa | Temperature: 5~40°C<br>Humidity: ≤ 80%RH<br>Atmospheric<br>Pressure: 86~106kPa | -- | SE |
| Storage<br>Environment | Temperature: -20 ~<br>55°C<br>Humidity: ≤ 95% RH<br>Atmospheric Pressure:<br>50~106 kPa | Temperature: -20 ~<br>55°C<br>Humidity: ≤ 95% RH<br>Atmospheric<br>Pressure: 50~106 kPa | Temperature: -20 ~<br>55°C<br>Humidity: ≤ 95% RH<br>Atmospheric<br>Pressure: 50~106 kPa | -- | SE |
| Biocompatibility | Complied with ISO<br>10993-5, ISO 10993-<br>10 | Complied with ISO<br>10993-5, ISO 10993-<br>10 | Complied with ISO<br>10993-5, ISO 10993-<br>10 | Complied with ISO<br>10993-5, ISO 10993-<br>10 | SE |

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# Comparison in Detail(s):

#### Note 1:

Although the "Design (shape)", "Dimensions", and "Patient Contacting Material" are a little different from the predicate devices, they all comply with ISO 10993 requirements. So the differences will not raise any safety or effectiveness issue.

# Final Conclusion:

The subject device XinBo Electrodes (Models: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro -III, Neck Therapy Pro -IV) are Substantial Equivalent to the predicate devices.

# 8. Date of the summary prepared: April 20, 2018