HEALTH EXPERT ELCTRONIC STIMULATOR

K133929 · Shenzhen Osto Technology Company Limited · NUH · Nov 12, 2014 · Neurology

Device Facts

• Record ID: K133929
• Device Name: HEALTH EXPERT ELCTRONIC STIMULATOR
• Applicant: Shenzhen Osto Technology Company Limited
• Product Code: NUH · Neurology
• Decision Date: Nov 12, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

PMS (Mode 1~8) It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS (Mode 9~25) To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.

Device Story

Portable, adapter-powered electronic stimulator (Models AST-300C/AST-300D) providing TENS and PMS therapy. Device inputs include user-selected operation modes (25 total) and intensity levels via control panel. Output delivered through 4 external electrode pads for body stimulation and 2 integrated electrode pads for sole stimulation; includes non-electrical massage roller. Operated by user in home/clinic setting. Device features LCD display for mode, intensity, and timer. Healthcare providers/users utilize output to facilitate muscle performance or manage pain. Safety features include automatic shut-off and user override. Device uses electrical pulses to stimulate nerves/muscles; performance verified via bench testing against electrical safety and biocompatibility standards.

Clinical Evidence

Bench testing only. Evaluated for electrical safety (IEC 60601-1, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993-5, ISO 10993-10), and usability (IEC 62366). Waveform output verified against FDA guidance for TENS and PMS devices.

Technological Characteristics

Portable, adapter-powered (100-240Vac input, 5Vdc output). ABS plastic housing. Type BF applied part. 2 output channels. Voltage-controlled, symmetric biphasic pulsed waveform with interphase interval. 25 operation modes, 99 intensity steps. Connectivity: wired electrode pads and integrated sole electrodes. Software-controlled. Biocompatible materials per ISO 10993.

Indications for Use

Indicated for healthy individuals requiring muscle performance improvement (PMS) or temporary pain relief in shoulder, waist, back, neck, arm, leg, and foot due to exercise or household strain (TENS).

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

• SM TENS & PMS Model SM9128 (K121719)
• Prospera OTC TENS Electronic Pulse Massager Model PL029 (K122744)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are drawn with thick, curved lines, creating a sense of depth and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

November 12, 2014

Shenzhen OSTO Technology Company Limited Li Yang, General Manager No.43 Longfeng Road Xinsheng Community, Longgang Street Longgang District, Shenzhen City Guangdong Province CHINA

Re: K133929

Trade/Device Name: Health Expert Electronic Stimulator, Model AST-300C and AST-300D Regulation Number: 21 CFR 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: NUH, NGX Dated: October 07, 2014 Received: October 10, 2014

Dear LiYang:

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. Isting 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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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.

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,

# Felipe Aquel -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) K133929

Device Name

Health Expert Electronic Stimulator, Model: AST-300C and AST-300D

Indications for Use (Describe)

PMS (Mode 1~8)

It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

- TENS (Mode 9~25)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.

Prescription Use (Part 21 CFR 801 Subpart D)

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

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| Sponsor: | Shenzhen OSTO Technology Company Limited |
|-----------------|-------------------------------------------------------------------|
| Subject Device: | Health Expert Electronic Stimulator, Model: AST-300C and AST-300D |
| File No.: | 510(k) submission report (V1.0) |
| Chapter 5 | 510(k) Summary |

#### Chapter 5. 510(k) Summary

#### 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: Shenzhen OSTO Technology Company Limited �
- 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 Manger) �
- Email: [e-mail] �

#### Subject Device Information 2.

- Health Expert Electronic Stimulator � Trade Name:
ll

- Electronic Stimulator Common Name: �
- Stimulator, Nerve, Transcutaneous, Muscle, Powered, For � Classification name: Muscle Conditioning, Over-The-Counter
- Neurology, Physical Medicine � Review Panel:
- NUH, NGX � Product Code:
- Regulation Class: �
- 882.5890, 890.5850 Requlation Number: �

#### Predicate Device Information 3.

| Sponsor | Hong Qiangxing (Shenzhen) Electronics Limited | Prospera Cprporation |
|-----------------------|-----------------------------------------------|-------------------------------------------------------------|
| Device Name and Model | SM TENS & PMS<br>Model: SM9128 | Prospera OTC TENS Electronic Pulse Massager<br>Model: PL029 |
| 510(k) Number | K121719 | K122744 |
| Product Code | NUH, NGX | NUH, NGX |
| Regulation Number | 882.5890, 890.5850 | 882.5890 |
| Regulation Class | II | II |

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| Sponsor: | Shenzhen OSTO Technology Company Limited |
|-----------------|-------------------------------------------------------------------|
| Subject Device: | Health Expert Electronic Stimulator, Model: AST-300C and AST-300D |
| File No.: | 510(k) submission report (V1.0) |
| Chapter 5 | 510(k) Summary |

## 4. Device Description

Health Expert Electronic Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities.

Health Expert Electronic Stimulator has 25 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body stimulation and 2 big electrode pads in Electrode Silicon Area for feet placed on the main unit to help users to enjoy sole stimulation, as well as certain non-electrical rolling massage through one massage roller.

The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key and Intensity Modification keys.

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

The device is equipped with accessories of electrode wire, adapter, remote controller. The electrode wire is used to connect the pads to the main unit; the adapter wire is used to connect the adapter to the device.

The electrode pads, which are provided by Shenzhen Context Kang Technology Company Limited complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.

# 5. Intended Use / Indications for Use

PMS (Mode 1~8)

It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS (Mode 9~25)

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

#### 6. Test Summary

Health Expert Electronic Stimulator has been evaluated the safety and performance by lab bench testing as following:

- � Electrical safety test according to IEC 60601-1 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 standards
- ◆ Usability test according to IEC 62366 standard
- � Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- � The waveform test report 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

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| Sponsor: | Shenzhen OSTO Technology Company Limited |
|-----------------|-------------------------------------------------------------------|
| Subject Device: | Health Expert Electronic Stimulator, Model: AST-300C and AST-300D |
| File No.: | 510(k) submission report (V1.0) |
| Chapter 5 | 510(k) Summary |

# 7. Comparison to predicate device and conclusion

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<br>Comparison | Subject Device | Predicate Device | | Remark |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Device Name and<br>Model | Health Expert Electronic<br>Stimulator<br>Model: AST-300C and<br>AST-300D | SM TENS & PMS<br>Model: SM9128 | Prospera OTC TENS<br>Electronic Pulse<br>Massager<br>Model: PL029 | -- |
| 510(k) Number | Applying | K121719 | K122744 | -- |
| Intended Use &<br>Indications for<br>Use | PMS (Mode 1~8)<br>It is intended to<br>stimulate healthy<br>muscles in order to<br>improve and facilitate<br>muscle performance.<br>TENS (Mode 9~25)<br>To be used for<br>temporary relief of pain<br>associated with sore and<br>aching muscles in the<br>shoulder, waist, back,<br>back of the neck, arm,<br>leg, and foot due to<br>strain from exercise or<br>normal household work<br>activities by applying<br>current to stimulate<br>nerve. | TENS (Mode 1, 3, 4, 5, 6):<br>To be used for temporary<br>relief of pain associated<br>with sore and aching<br>muscle in the shoulder,<br>waist, back, neck, upper<br>extremities (arm), and<br>lower extremities (legs)<br>due to strain from<br>exercise or normal<br>household work activities.<br>PMS (Mode 1, 2, 3, 6):<br>It is intended to be used to<br>stimulate healthy muscle<br>in order to improve and<br>facilitate muscle<br>performance. | To be used for<br>temporary relief of pain<br>associated with sore<br>and aching muscle in<br>the shoulder, waist,<br>back, neck, upper<br>extremities (arm), and<br>lower extremities (legs)<br>due to strain from<br>exercise or normal<br>household work<br>activities. | SE |
| Basic Unit Characteristics | | | | |
| Power Source(s) | Adaptor Input: 100-<br>240Vac, 50-60Hz, 0.1A<br>Output: 5Vdc, 1A<br>Unit Input: 5Vdc, 1A | DC 3.7V Lithium Battery | DC 3V Lithium<br>Battery | SE<br>Note1 |
| -Method of Line<br>Current Isolation | Type BF Applied Part | Type BF Applied Part | Type BF Applied Part | SE |

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| Sponsor: | Shenzhen OSTO Technology Company Limited | |
|-----------------|-------------------------------------------------------------------|--|
| Subject Device: | Health Expert Electronic Stimulator, Model: AST-300C and AST-300D | |
| File No.: | 510(k) submission report (V1.0) | |
| Chapter 5 | 510(k) Summary | |

| Elements of Comparison | Subject Device | Predicate Device | Remark | |
|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|---------------------------------|--------------|
| Patient Leakage Current | NC AC: 54.5µA, DC: 0.5µA | 2.0μΑ | 2.0μΑ SE Note 1 | |
| | SFC AC:120.0µA, DC: 0.6μΑ | < 10μΑ | 3.3μΑ | |
| Average current through electrodes when device is on but no pulses are being applied | DC < 0.01μA | < 0.01μA | 0μΑ SE Note 1 | |
| Number of Output Channels: | 2 | 2 | 2 SE | |
| Number of Output Modes | 25 | 6 | 8 SE Note 2 | |
| Output Intensity Level | 99 steps | 20 steps | -- SE Note 2 | |
| Synchronous or Alternating? | Synchronous | Synchronous | Alternating SE Note 2 | |
| Method of Channel Isolation | Voltage Transform Isolation<br>"BODY▼" and<br>"BODY▼" buttons for body channel,<br>"SOLE▲" and<br>"SOLE▼" buttons for feet channel | Voltage Isolation | Transform By software SE Note 2 | |
| Regulated Current or Regulated Voltage? | Voltage Control | Voltage Control | Voltage Control SE | |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes SE | |
| Automatic Overload Trip | No | No | No SE | |
| Automatic Load Trip | No- No | No | No SE | |
| Elements of<br>Comparison | Subject Device | Predicate Device | Remark | |
| Automatic Shut<br>Off | Yes. | -- | Yes | SE |
| User Override<br>Control | Yes | Yes | Yes | SE |
| Indicator On/Off<br>Display Status | Yes | Yes | Yes | SE |
| Low<br>Battery | No | -- | No | SE |
| Voltage/<br>Current<br>Level | Yes | Yes | -- | SE |
| Timer Range | 25min | 10-60 minutes, 10<br>min/step | 5min, 10min | SE<br>Note 2 |
| Weight | 2Kg<br>(Without<br>accessories) | -- | 0.18Kg | SE<br>Note 2 |
| Dimensions | 428mm x 428.8mm x<br>185mm | -- | 707mm x 2398mm x<br>253mm | SE<br>Note 2 |
| Housing Materials<br>and Construction | Main unit: ABS plastic | -- | Enclosure: ABS | SE |
| Output Specifications | | | | |
| Waveform | Pulsed, symmetric,<br>biphasic | Pulsed, symmetric,<br>biphasic | Monophasic | SE |
| Shape | Rectangular, with<br>interphase interval | Rectangular, with<br>interphase interval | Rectangular | SE |
| Maximum Output<br>Voltage | 44V±10% @ 500Ω | 42V±10% @ 500Ω | 49.6V±20% @ 500Ω | SE<br>Note 3 |
| | 80V±10% @ 2KΩ | 84V±10% @ 2KΩ | 99.2V±20% @ 2KΩ | |
| | 112V±10% @ 10KΩ | 130V±10% @ 10KΩ | 114V±20% @ 10KΩ | |
| Maximum Output<br>Current | 88mA±10% @ 500Ω | 84mA±10% @ 500Ω | 18mA±20% @ 500Ω | SE<br>Note 3 |
| | 40mA±10% @ 2KΩ | 42mA±10% @ 2KΩ | 3.2mA±20% @ 2KΩ | |
| | 11.2mA±10% @ 10KΩ | 13mA±10% @10KΩ | 0.6mA±20% @ 10KΩ | |
| Pulse Duration | 120μs | 100μs | 100~200μs | SE<br>Note 3 |
| Pulse frequency | 77.3Hz | 1~110Hz | 0.5~86Hz | SE<br>Note 3 |

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Shenzhen OSTO Technology Company Limited Sponsor: Health Expert Electronic Stimulator, Model: AST-300C and AST-300D Subject Device: File No.: 510(k) submission report (V1.0) Chapter 5 510(k) Summary

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| Sponsor: | Shenzhen OSTO Technology Company Limited |
|-----------------|-------------------------------------------------------------------|
| Subject Device: | Health Expert Electronic Stimulator, Model: AST-300C and AST-300D |
| File No.: | 510(k) submission report (V1.0) |
| Chapter 5 | 510(k) Summary |

| Elements of<br>Comparison | Subject Device | Predicate Device | Remark | |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------|
| Net Charge (per<br>pulse) | 0µC @ 500Ω<br>Method: Balanced<br>waveform | 0µC @ 500Ω,<br>Method: Balanced<br>waveform | 18000µC @ 500Ω | SE<br>Note 3 |
| Maximum Phase<br>Charge | 12.78µC @ 500Ω | 16.80µC @ 500Ω | 23.00µC @ 500Ω | SE<br>Note 3 |
| Maximum<br>Average Current | 0.968mA @ 500Ω | 0.924mA @ 500Ω | -- | SE<br>Note 3 |
| Maximum Current<br>Density (r.m.s ) | 0.235mA/cm² @ 500Ω | 0.462mA/cm² @500Ω | 1.4mA/cm² @500Ω | SE<br>Note 3 |
| Maximum<br>Average Power<br>Density | 1.38mW/cm² @ 500Ω | 9.702m W/cm² @500Ω | 0.23W/cm² @ 500Ω | SE<br>Note 3 |
| ON Time | 0.6s | -- | 40ms | SE<br>Note 3 |
| OFF Time | 0.6s | -- | 18ms | SE<br>Note 3 |
| Additional Features | | | | |
| Environment for<br>operating | Temperature: 5 ~ 45°C<br>Humidity: 20 ~ 65% RH | Temperature: 5 ~ 40°C<br>Humidity: ≤80% RH | -- | SE<br>Note 1 |
| Environment for<br>storage | Temperature: 0 ~ 45°C,<br>Humidity: 10 ~ 90% RH<br>Electrode Pad: 10~20°C | Temperature: -20 ~ 55°C<br>Humidity: ≤93% RH | -- | SE<br>Note 1 |
| Standards | | | | |
| Biocompatibility | All user directly<br>contacting materials are<br>compliance with<br>ISO10993-5 and<br>ISO10993-10<br>requirements. | All user directly contacting<br>materials are compliance with<br>ISO10993-5 and ISO10993-10<br>requirements. | All user directly<br>contacting materials<br>are compliance with<br>ISO10993-5 and<br>ISO10993-10<br>requirements. | SE |
| Electrical Safety | Comply with IEC 60601-<br>1 and IEC 60601-2-10 | Comply with IEC 60601-1<br>and IEC 60601-2-10 | Comply with IEC<br>60601-1 and IEC<br>60601-2-10 | SE<br>IEC |
| EMC | Comply with IEC 60601-<br>1-2 | Comply with IEC 60601-1-<br>2 | Comply with<br>60601-1-2 | IEC SE |

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| Sponsor: | Shenzhen OSTO Technology Company Limited |
|-----------------|-------------------------------------------------------------------|
| Subject Device: | Health Expert Electronic Stimulator, Model: AST-300C and AST-300D |
| File No.: | 510(k) submission report (V1.0) |
| Chapter 5 | 510(k) Summary |

# Comparison in Detail(s):

## Note 1:

Although the " Power Source(s)", " Patient Leakage Current", "Average DC current through electrodes when device is on but no pulses are being applied", "Operating Environment" are a little different from the predicate devices, they all comply with IEC 60601-1 requirements. So the differences will not raise any safety or effectiveness issue.

# Note 2:

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 "Maximum Output Voltage", "Maximum Output Current", "Maximum pulse frequency", "Net Charge (per pulse)", "Maximum Phase Charge", "Maximum Average Current", "Maximum Current Density", "Maximum Average Power Density of subject device", "ON Time" and "OFF Time" are a little different from the predicate devices, they all comply with IEC 60601-1, IEC 60601-2-10 requirement, FDA quidance 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.

#### Finial Conclusion:

The subject device "Health Expert Electronic Stimulator" is Substantial Equivalent to the predicate devices.

#### 8. Date of the summary prepared: November 1, 2014