Neck Care Therapy, Model: SYK 509B

K172897 · Shenzhen Osto Technology Co., Ltd. · NUH · Dec 7, 2018 · Neurology

Device Facts

• Record ID: K172897
• Device Name: Neck Care Therapy, Model: SYK 509B
• Applicant: Shenzhen Osto Technology Co., Ltd.
• Product Code: NUH · Neurology
• Decision Date: Dec 7, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of neck, back, arm, and leg, due to strain from exercise or normal household and work activities. - Neck Pad is used in back of neck. - Meridian Pad is used in shoulder, waist, back, and arm.

Device Story

Household multifunctional electrotherapy device; uses low-frequency electrical pulses and circular traction vibration to alleviate muscle pain. Inputs: user-selected mode and intensity via remote control. Processing: microprocessor-controlled electrical pulse generation delivered through electrode pads or integrated neck pad. Output: pulsed, symmetric, biphasic electrical stimulation to skin. Operated by patient (OTC); remote control features ON/OFF, intensity adjustment, and mode selection. LCD displays mode, intensity, and remaining time. Safety interlock requires simultaneous activation of remote and neck pad. Benefits: temporary pain relief via nerve/muscle stimulation.

Clinical Evidence

Bench testing only. Evaluated via electrical safety (IEC 60601-1, 60601-1-11, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993-5, ISO 10993-10), usability (IEC 62366), and software verification/validation. Waveform output verified against FDA guidance for TENS/muscle stimulators.

Technological Characteristics

Transcutaneous electrical nerve stimulator (TENS). Materials: ABS plastic housing; electrode pads (silica gel, conductive silicone, adhesive silicone, PET silicone, stainless steel). Energy: 3.7Vdc battery or 5Vdc adapter. Output: Pulsed, symmetric, biphasic waveform; 120us pulse duration; 77.3Hz frequency. Connectivity: Standalone. Software: Microprocessor-controlled. Sterilization: N/A.

Indications for Use

Indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of neck, back, arm, and leg, due to strain from exercise or normal household and 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

• Health Expert Electronic Stimulator (K133929)

Submission Summary (Full Text)

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December 7, 2018

Shenzhen OSTO Technology Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, 510006 China

Re: K172897

Trade/Device Name: Neck Care Therapy, Model: SYK-509B Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: November 2, 2018 Received: November 8, 2018

Dear 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. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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.

# Pamela D. Scott -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) K172897

Device Name Neck Care Therapy (model: 905B)

Indications for Use (Describe)

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.

- -Neck Pad is used in back of neck.
- Meridian Pad is used in shoulder, waist, back, and arm. -

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

| | Research Use Only (RUO) unless Subject to Other Claims |
|--|--------------------------------------------------------------|
| | In-Vitro Diagnostic Use (IVD) unless Subject to Other Claims |

| | 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 K172897

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: Shenzhen OSTO Technology Co., Ltd. Establishment Registration Number: Applying Address: No.43 Longfeng Road, Xinsheng Community, Longgang Street Longgang District, Shenzhen City Guangdong Province, CHINA Tel: [phone] Fax: [phone] Contact Person: Li Yang (General Manager) Email: [e-mail]

## Application Correspondent:

Contact Person: 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: Neck Care Therapy Common Name: Electronic Stimulator Classification name: Transcutaneous electrical nerve stimulator for pain relief, Transcutaneous Electrical Nerve Stimulator, Muscle, Powered, For Muscle Conditioning Review Panel: Neurology Product Code: NUH, NGX Regulation Class: II Regulation Number: 21 CFR 882.5890, 890.5850

#### 3. Predicate Device Information

Sponsor: Shenzhen OSTO Technology Company Limited Trade Name: Health Expert Electronic Stimulator Common Name: Electronic Stimulator Classification name: Stimulator, Nerve, Transcutaneous, Muscle, Powered, For Muscle Conditioning, Over-The-Counter 510(k)number: K133929 Review Panel: Neurology, Physical Medicine Product Code: NUH, NGX Regulation Number: 882.5890, 890.5850 Regulation Class: II

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# 4. Device Description

This instrument is a new generation of household multifunctional device based on physics, modern microelectronics and clinical practices, it uses low frequency electrotherapy, and circular traction vibration to temporarily alleviate the pain associated with sore and aching muscles in the shoulder, waist, back of neck, back, arm, and leg. The Neck Pad is used in for back of neck and it accord with human body cervical physiological curvature of streamlined ring design accord with human body cervical physiological curvature of streamlined ring design. The Meridian Pad is used in shoulder, waist, back, and arm. The device has one operation modes which has 2 modes and 50 output Intensity Level, so the device can give certain electrical pulse through 2 pairs of electrode pads or the Neck Pad on the skin to help users to enjoy body massage and sole massage.

The remote control of this device is user-friendly controlled because it has the operating elements of ON/OFF knob, left or right button and increase or decrease button.

The device is equipped with accessories of electrode pads and an electrode wire is used to connect the pads to the main unit.

The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode.

The device can be successfully opened only when switch button of the remote control and Neck Pad turned on at the same time.

The remote control is the only controller to select the pulse intensity and adjust the treatment time.

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

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of neck, back, arm, and leg, due to strain from exercise or normal household and work activities.

- Neck Pad is used in back of neck. ।
- -Meridian Pad is used in shoulder, waist, back, and arm.

# 6. Test Summary

Neck Care Therapy, Model: AST-905B has been evaluated the safety and performance by lab bench testing as following:

- Electrical safety test according to IEC 60601-1, IEC 60601-1-11 and IEC 60601-2-10 standards �
- � Electromagnetic compatibility test according to IEC 60601-1-2 standard
- � Biocompatibility test according to ISO 10993-5 and ISO 10993-10
- � Usability test according to IEC 62366 standard
- � Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
- � The waveform test has also been conducted to verify the output specifications of the device according to "Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning".

#### 7. Comparison to predicate device and conclusion

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The technological characteristics, features, specifications, materials, mode of operation, and intended use of Electronic Muscle Stimulator is substantially equivalent to the predicate devices quoted above.

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

| Elements of comparison | Subject<br>K172897 | device | Predicate<br>K133929 | device | Remark |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Device name and model | AST-905B<br>200B | Neck Care Therapy<br>or SYK- | Health | Expert<br>Electronic Stimulator | |
| Intended Use & Indications for<br>Use | temporary<br>sore<br>muscles<br>from<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | To be used for<br>relief<br>of<br>pain associated with<br>and<br>aching<br>in<br>the<br>shoulder, waist, back<br>of neck, back, arm,<br>and leg, due to strain<br>exercise<br>or<br>normal household and<br>work activities.<br>— Neck Pad is<br>used in back of neck.<br>Meridian Pad is<br>used in shoulder,<br>waist, back, and arm | stimulate<br>9~25)<br>To<br>sore<br>muscles<br>normal<br>work | PMS (Mode 1~8)<br>It is intended to<br>healthy<br>muscles in order to<br>improve and facilitate<br>muscle performance.<br>TENS<br>(Mode<br>be<br>used<br>for<br>temporary relief<br>of<br>pain associated with<br>and aching<br>in<br>the<br>shoulder, waist, back,<br>back of the neck, arm,<br>leg, and foot due to<br>strain from exercise or<br>household<br>activities<br>by<br>applying current<br>to<br>stimulate nerve. | Similar intended<br>use and IFU |
| Power Source(s) | C, | Main Unit:<br>Power Adaptor:<br>Input:100~240Va<br>50/60Hz, 0.2A;<br>Output: 5Vdc, 1A | 100-<br>0.1A | Adaptor<br>Input:<br>240Vac, 50-60Hz,<br>Output: 5Vdc, 1A<br>Unit Input: 5Vdc, 1A | Similar |
| | 500mAh | Battery:<br>3.7Vdc, | 500mAh | Battery:<br>3.7Vdc, | Identical |
| | AAA x 2<br>1 A | Remote Control:<br>Battery:<br>3Vdc,<br>Unit Input: 5Vdc, | AAA x 2<br>1 A | Remote Control:<br>Battery:<br>3Vdc,<br>Unit Input: 5Vdc, | Identical |
| Current<br>Method<br>of<br>Line<br>Isolation | Part | Type BF Applied | Part | Type BF Applied | Identical |
| Patient Leakage Current | NC<br>SFC | AC: 54.5uA<br>DC: 0.5uA<br>AC: 120uA | NC<br>SFC | AC: 54.5uA<br>DC: 0.5uA<br>AC: 120.0uA | Identical |

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| | DC: 0.6uA | DC: 0.6uA | DC: 0.6uA |
|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Average current through<br>electrodes when device is on but<br>no pulses are being applied | <0.01uA | <0.01uA | Identical |
| Number of Output Modes | 2 | 25 | Doesn't affect<br>safety and<br>effectiveness<br>*See note 1 |
| Output Intensity Level | 50 steps | 99 steps | Doesn't affect<br>safety and<br>effectiveness<br>*See note 1 |
| Synchronous or Alternating? | Synchronous | Synchronous | Identical |
| Method of Channel Isolation | Voltage<br>Transform<br>Isolation | Voltage<br>Transform<br>Isolation | Identical |
| Regulated Current or<br>Regulated Voltage? | Voltage Control | Voltage Control | Identical |
| Software/Firmware/Microproc<br>essor Control? | Yes | Yes | Identical |
| Automatic Overload Trip | No | No | Identical |
| Automatic No-Load Trip | No | No | Identical |
| Automatic Shut Off | Yes | Yes | Identical |
| User Override Control | Yes | Yes | Identical |
| Timer Range | 5-30 min | 25 min | Similar<br>*See note 1 |
| Weight | Main Unit:<br>AST-905B: 222g<br><br>Electrode:<br>Patch Electrode: 44g | 2kg (Without<br>accessories) | Doesn't affect<br>safety and<br>effectiveness |
| Dimensions | Main Unit:<br>AST-905B:<br>187.2*169*67.3 mm<br><br>Electrode:<br>Patch Electrode: 8.9 cm<br>*5.8 cm | 428mm x 428.8mm<br>x<br>185mm<br><br>Electrode:<br>Patch Electrode: 8.9 cm<br>*5.8 cm | Identical<br>electrode area |
| Electrode pads | Electrode Pads:<br>White silica gel, Black<br>conductive silicone,<br>Transparent conductive<br>adhesive silicone, Transparent<br>PET silicone | Electrode Pads:<br>White silica gel, Black<br>conductive silicone,<br>Transparent conductive<br>adhesive silicone, Transparent<br>PET silicone | Identical |
| | Sticky<br>metal<br>sheet: Stainless steel | PP conductive plastic | Complies with IEC<br>10993-5<br>and<br>10993-10. |
| | | | |
| Housing unit | ABS plastic | ABS plastic | Identical |
| Waveform | Pulsed.<br>symmetric,<br>biphasic | Pulsed,<br>symmetric,<br>biphasic | Identical |
| Shape | Rectangular, with<br>interphase interval | Rectangular, with<br>interphase interval | Identical |
| Maximum Output Voltage | 44V±10%<br>ರಿ<br>500Ω<br>80V±10% @ 2KΩ<br>112V±10% @ 10KΩ | 44V±10% @ 500Ω<br>80V±10% @ 2KΩ<br>112V±10% @ 10KΩ | Identical |
| Maximum Output Current | 88mA±10%<br>ರಿ<br>500Ω<br>40mA±10%<br>ರಿ<br>2KQ<br>11.2mA±10% @ 10KΩ | 88mA±10%<br>ರಿ<br>500Ω<br>ത<br>40mA±10%<br>2KΩ<br>11.2mA±10% @ 10KΩ | Identical |
| Pulse Duration (us) | 120us | 120us | Identical |
| Pulse frequency | 77.3Hz | 77.3Hz | Identical |
| Net Charge (per pulse) | 0µC @ 500Ω<br>Method:<br>Balanced<br>waveform | 0µC @ 500Ω<br>Method:<br>Balanced<br>waveform | Identical |
| Phase<br>Charge<br>Maximum<br>(a)<br>500Ω | 12.78μC | 12.78μC | Identical |
| Maximum<br>Average<br>Current@<br>500Ω | 0.968 mA | 0.968 mA | Identical |
| Maximum<br>Current<br>Density<br>(r.m.s) @ 500Ω | 0.235 mA/cm² | 0.235 mA/cm² | Identical |
| Maximum<br>Average<br>Power<br>Density @ 500Ω | 1.38 mW/cm² | 1.38 mW/cm² | ldentical |
| Operating Environment | Temperature:<br>5~40°C<br>Humidity: 15%<br>90%RH<br>Atmospheric<br>Pressure: 700 hPa to<br>1060 hPa | Temperature: 5 ~<br>45°C<br>Humidity: 20 ~ 65% RH | Similar |
| Storage Environment | Temperature:<br>-25<br>+70°CHumidity:<br><90%<br>RH,<br>Atmospheric<br>Pressure: 700 hPa to<br>1 060 hPa | Temperature: 0<br>-<br>45°C,<br>Humidity:<br>10<br>ﮧ<br>90% RH<br>Electrode<br>Pad:<br>10~20°C | Similar |
| Biocompatibility | Biocompatibility<br>test<br>according<br>ાકભ<br>to<br>ાકભ<br>10993-5<br>and<br>10993-10 | All<br>directly<br>user<br>contacting materials are<br>compliance<br>with<br>ISO10993-5<br>and<br>ISO10993-10<br>requirements. | Identical |
| Electrical Safety | Comply<br>with<br>IEC<br>60601-1<br>IEC<br>and<br>60601-2-10 | Comply<br>with<br>IEC<br>IEC<br>60601-1<br>and<br>60601-2-10 | Identical |
| EMC | Comply<br>with<br>IEC<br>60601-1-2 | Comply<br>with<br>IEC<br>60601-1-2 | Identical |

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# Comparison in Detail(s):

# Note 1 (Time Range, Number of Output Modes, Output Intensity Level):

The design of the time range, Number of Output Modes and Output Intensity Level is basing on the intended use. And according to the output specification comparing with the predicated devices, we set the default treatment time is 15min and the user could adjust the levels which could meet the requirements in the energy aspect. Thus, the subject device is actually the same as predicated ones.

## Finial Conclusion:

Based on the above analysis and tests performed, it can be concluded that Neck Care Therapy device is effective, and it is Substantially Equivalent (SE) to the predicate device.

#### 8. Date of the summary prepared: December 7, 2018