Health Expert Electronic Stimulator

K190673 · Shenzhen Osto Technology Company Limited · NUH · Dec 12, 2019 · Neurology

Device Facts

• Record ID: K190673
• Device Name: Health Expert Electronic Stimulator
• Applicant: Shenzhen Osto Technology Company Limited
• Product Code: NUH · Neurology
• Decision Date: Dec 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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; provides TENS and PMS therapy. Inputs: user-selected operation mode (25 total) and intensity levels (99 steps). Device delivers electrical pulses via 4 external electrode pads or 2 integrated foot-sole electrodes. Operation: user selects mode/intensity via control panel; LCD displays status, intensity, and timer. Device uses symmetric, biphasic, rectangular pulsed waveforms. Intended for OTC use to facilitate muscle performance or provide temporary pain relief. Benefits: non-invasive muscle conditioning and pain management. Healthcare provider role: none; device is for patient self-use.

Clinical Evidence

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

Technological Characteristics

ABS plastic housing; Type BF applied part; voltage-controlled output; 2 channels; 25 modes; 99 intensity steps. Waveform: pulsed, symmetric, biphasic, rectangular. Power: 100-240Vac adapter. Biocompatibility: ISO 10993-5/10 compliant. Connectivity: standalone. Software: microprocessor-controlled with automatic shut-off.

Indications for Use

Indicated for healthy adults requiring muscle performance improvement (PMS) or temporary relief of pain 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

• Health Expert Electronic Stimulator, Model AST-300C and AST-300D (K133929)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 12, 2019

Shenzhen OSTO Technology Company Limited % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Room 2231, Building 1, Ruifeng Center, Kaichuang Road Huangpu District Guangzhou, 51006 CN

Re: K190673

Trade/Device Name: Health Expert Electronic Stimulator, Models AST-300F, AST-300H, AST-300J Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: September 7, 2019 Received: September 13, 2019

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

{1}------------------------------------------------

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/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 medical devices and radiation-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,

Pamela D. 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K190673

Device Name

Health Expert Electronic Stimulator (model: AST-300F, AST-300H, AST-300J)

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.

| 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

### 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: 3011564440 �
- 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]

#### 2. Application Correspondent:

- � Contact Person: Ms. Cassie Lee
- Guangzhou GLOMED Biological Technology Co., Ltd. �
- Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, � Guangdong, China
- � Tel: [phone]

Email: [e-mail]

#### 3. Subject Device Information

- Health Expert Electronic Stimulator � Trade Name:
- 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:
- ll � Regulation Class:
- 882.5890, 890.5850 � Regulation Number:

#### 4. Predicate Device Information

| Sponsor | Shenzhen OSTO Technology Company Limited |
|-----------------------|---------------------------------------------------------------------|
| Device Name and Model | Health Expert Electronic Stimulator<br>Model: AST-300C and AST-300D |
| 510(k) Number | K133929 |
| Product Code | NUH, NGX |
| Regulation Number | 882.5890, 890.5850 |

{4}------------------------------------------------

| Regulation Class | II |
|------------------|----|
|------------------|----|

## 2. 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.

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 60601-1-11 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 standards
- � Usability test according to IEC 62366-1 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

### 7. Comparison to predicate device and conclusion

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

{5}------------------------------------------------

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-300F, AST-<br>300H, AST-300J | Health Expert Electronic<br>Stimulator<br>Model: AST-300C and<br>AST-300D | -- | |
| 510(k) Number | Applying | K133929 | -- | |
| Intended Use | PMS (Mode 1~8)<br>It is intended to stimulate<br>healthy muscles in order to improve and facilitate<br>muscle performance.<br>TENS (Mode 9~25)<br>To be used for temporary<br>relief of pain associated<br>with sore and aching<br>muscles in the shoulder,<br>waist, back, back of the<br>neck, arm, leg, and foot<br>due to strain from exercise<br>or normal household work<br>activities by applying<br>current to stimulate nerve. | PMS (Mode 1~8)<br>It is intended to stimulate<br>healthy muscles in order<br>to improve and facilitate<br>muscle performance.<br>TENS (Mode 9~25)<br>To be used for temporary<br>relief of pain associated<br>with sore and aching<br>muscles in the shoulder,<br>waist, back, back of the<br>neck, arm, leg, and foot<br>due to strain from<br>exercise or normal<br>household work activities<br>by applying current to<br>stimulate nerve. | SE | |
| Power Source(s) | Adaptor Input: 100-<br>240Vac, 50-60Hz, 0.1A<br>Output: 5Vdc, 1A<br>Unit Input: 5Vdc, 1A | Adaptor Input: 100-<br>240Vac, 50-60Hz, 0.1A<br>Output: 5Vdc, 1A<br>Unit Input: 5Vdc, 1A | SE | |
| -Method of Line<br>Current Isolation | Type BF Applied Part | Type BF Applied Part | SE | |
| Patient<br>Leakage<br>Current | NC | AC: 54.5μA, DC: 0.5μA | AC: 54.5μA,<br>DC: 0.5μA | SE |
| | SFC | AC:120.0μΑ, DC: 0.6μΑ | AC:120.0μA, DC: 0.6μΑ | SE |
| Average DC<br>current through<br>electrodes when<br>device is on but<br>no pulses are<br>being applied | | < 0.01μA | < 0.01μA | SE |
| Elements of<br>Comparison | Subject Device | Predicate Device | Remark | |
| Number of Output<br>Channels: | 2 | 2 | SE | |
| Number of Output<br>Modes | 25 | 25 | SE | |
| Output Intensity<br>Level | 99 steps | 99 steps | SE | |
| Synchronous or<br>Alternating? | Synchronous | Synchronous | SE | |
| Method of<br>Channel Isolation | Voltage Transform<br>Isolation<br>"Body-" and "Body-"<br>buttons for body channel,<br>"Sole+" and "Sole-" buttons<br>for feet channel | Voltage Transform<br>Isolation<br>"Body ▼" and "Body▼"<br>buttons for body channel,<br>"Sole ▲" and "Sole ▼ "<br>buttons for feet channel | SE | |
| Regulated<br>Current or<br>Regulated<br>Voltage? | Voltage Control | Voltage Control | SE | |
| Software/Firmwar<br>e/Microprocessor<br>Control? | Yes | Yes | SE | |
| Automatic<br>Overload Trip | No | No | SE | |
| Automatic No-<br>Load Trip | No | No | SE | |
| Automatic Shut<br>Off | Yes. | Yes | SE | |
| User Override<br>Control | Yes | Yes | SE | |
| Indicator<br>Display | On/Off<br>Status | Yes | Yes | SE |
| | Low<br>Battery | No | No | SE |
| | Voltage/<br>Current<br>Level | Yes | Yes | SE |
| Timer Range | 25min | 25min | SE | |
| Elements of<br>Comparison | Subject Device | Predicate Device | Remark | |
| Weight | 1.9Kg (Without<br>accessories) | 2Kg (Without accessories) | SE<br>Note 1 | |
| Dimensions | 429.1mm x 426.6mm x<br>153.8mm | 428mm x 428.8mm x<br>185mm | SE<br>Note 1 | |
| Housing Materials<br>and Construction | Main unit: ABS plastic | Main unit: ABS plastic | SE | |
| Waveform | Pulsed, symmetric,<br>biphasic | Pulsed, symmetric,<br>biphasic | SE | |
| Shape | Rectangular, with<br>interphase interval | Rectangular, with<br>interphase interval | SE | |
| Maximum Output<br>Voltage | 44V±10% @ 500Ω<br>80V±10% @ 2KΩ<br>112V±10% @ 10KΩ | 44V±10% @ 500Ω<br>80V±10% @ 2KΩ<br>112V±20% @ 10KΩ | SE | |
| Maximum Output<br>Current | 88mA±10% @ 500Ω<br>40mA±10% @ 2KΩ<br>11.2mA±10% @ 10KΩ | 88mA±10% @ 500Ω<br>40mA±10% @ 2KΩ<br>11.2mA±10% @ 10KΩ | SE | |
| Pulse Duration | 120µs | 120µs | SE | |
| Pulse frequency | 77.3Hz | 77.3Hz | SE | |
| Net Charge (per<br>pulse) | 0µC @ 500Ω<br>Method: Balanced<br>waveform | 0µC @ 500Ω<br>Method: Balanced<br>waveform | SE | |
| Maximum Phase<br>Charge | 10.56µC @ 500Ω | 12.78µC @ 500Ω | SE | |
| Maximum<br>Average Current | 1.63mA @ 500Ω | 0.968mA @ 500Ω | SE | |
| Maximum Current<br>Density<br>(r.m.s ) | 0.0326mA/cm² @ 500Ω | 0.235mA/cm² @500Ω | SE | |
| Maximum<br>Average Power<br>Density | 0.000651mW/cm² @ 500Ω | 1.38mW/cm² @ 500Ω | SE | |
| ON Time | 0.6s | 0.6s | SE | |
| OFF Time | 0.6s | 0.6s | SE | |
| Elements of<br>Comparison | Subject Device | Predicate Device | Remark | |
| | | | | |
| Environment for<br>operating | Temperature: 5 ~ 45° C<br>Humidity: 20 ~ 65% RH | Temperature: 5 ~ 45°C<br>Humidity: 20 ~ 65% RH | SE | |
| Environment for<br>storage | Temperature: 0 ~ 45°C,<br>Humidity: 10 ~ 90% RH<br>Electrode Pad: 10~20°C | Temperature: 0 ~ 45°C,<br>Humidity: 10 ~ 90% RH<br>Electrode Pad: 10~20°C | SE | |
| Biocompatibility | All user directly contacting<br>materials are compliance<br>with ISO10993-5 and<br>ISO10993-10<br>requirements. | All user directly contacting<br>materials are compliance<br>with ISO10993-5 and<br>ISO10993-10<br>requirements. | SE | |
| Electrical Safety | Comply with IEC 60601-1<br>and IEC 60601-2-10 | Comply with IEC 60601-1<br>and IEC 60601-2-10 | SE | |
| EMC | Comply with IEC 60601-1-<br>2 | Comply with IEC 60601-1-<br>2 | SE | |

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

### Comparison in Detail(s):

Note 1: Although the " Weight" and "Dimensions"are a little different from the predicate device, but the differences will not raise any safety or effectiveness issue.

## Finial Conclusion:

The subject devices "Health Expert Electronic Stimulator, model AST-300F, AST-300H, AST-300J" are Substantial Equivalent to the predicate device K133929.

### 8. Date of the summary prepared: December 4, 2019