Health Expert Electronic Stimulator (model: AST-300L)

K190783 · Shenzhen Osto Technology Company Limited · NUH · Mar 14, 2020 · Neurology

Device Facts

• Record ID: K190783
• Device Name: Health Expert Electronic Stimulator (model: AST-300L)
• Applicant: Shenzhen Osto Technology Company Limited
• Product Code: NUH · Neurology
• Decision Date: Mar 14, 2020
• 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 modes (25 total), intensity levels (99 steps), and heating settings (30-40°C). Operation: device delivers electrical pulses via 4 external electrode pads or 2 integrated foot-sole electrodes; heating and stimulation can be applied simultaneously or alternatively. Used in home/clinic settings by patients. Output: electrical stimulation and superficial heat. Healthcare providers/patients use LCD screen to monitor mode, intensity, and remaining time. Benefits: muscle conditioning and temporary pain relief.

Clinical Evidence

Bench testing only. Evaluated via electrical safety (IEC 60601-1, 60601-1-11, 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

Portable stimulator; ABS plastic housing. Sensing/actuation: voltage-controlled electrical stimulation (biphasic, symmetric, rectangular waveform) and resistive heating (30-40°C). Power: AC adapter (100-240Vac). Connectivity: standalone. Applied parts: Type BF. Biocompatible electrode pads (ISO 10993). Software: microprocessor-controlled with 25 modes and 99 intensity levels.

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 (AST-300C and AST-300D) (K133929)
• Heat Pain Pro (K160115)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains 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.

March 14, 2020

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

Re: K190783

Trade/Device Name: Health Expert Electronic Stimulator (model: AST-300L) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: February 7, 2020 Received: February 10, 2020

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.

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

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) 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 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 Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

510(k) Number (if known) K190783

Device Name

Health Expert Electronic Stimulator (model: AST-300L)

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)

## 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, HuangpuDistrict, Guangzhou, � Guangdong, China
- � Tel: [phone]
- Email: [e-mail] �

## 3. Subject Device Information

- Health Expert Electronic Stimulator (model: AST-300L) � Trade Name:
- Common Name: Transcutaneous electrical nerve stimulator for pain relief �
- Stimulator, Nerve, Transcutaneous, Over-the-Counter � Classification name:
- Neurology, Physical Medicine � Review Panel:
- NUH, NGX Product Code: �
- Regulation Class: ll �
- Regulation Number: 882.5890, 890.5850 �

## 2. Predicate Device Information

## Predicate Device 1:

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

#### 510(K) Number: K133929

Company Name: Shenzhen OSTO Technology Company Limited

Trade Name: Health Expert Electronic Stimulator

Model: AST-300C and AST-300D

Common Name: Transcutaneous electrical nerve stimulator for pain relief

Regulation Number: 882.5890, 890.5850

Regulatory Class: II

Product Code: NUH, NGX

Use: Over-The-Counter Use

#### Predicate Device 2:

510(K) Number: K160115 Company Name: Omron Healthcare, Inc. Trade Name: Heat Pain Pro Common Name: Transcutaneous electrical nerve stimulator for pain relief Regulation Number: 882.5890 Regulatory Class: II Product Code: NUH Use: Over-The-Counter Use

### 3. 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

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

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, remote control ON/OFF key, Display screen, Heating adjust key, 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 Heating adjust key can help user to select a temperature for warming sensation of the foot range 30 to 40 degree C, the superficial heating time is same as the treatment time you selected. The superficial heating and electrical stimulation can apply simultaneously or apply alternatively. The device is equipped with accessories of electrode wire, adapter, remote controller. The electrode wire is used to connect 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.

### 4. 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.

## 5. 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, 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"

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

- � 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
## 6. 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 1 | Predicate Device 2 | Remark | |
|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Device Name and<br>Model | Health Expert Electronic<br>Stimulator<br>Model: AST-300L | Health Expert Electronic<br>Stimulator<br>Model: AST-300C and<br>AST-300D | Heat Pain Pro | -- | |
| 510(k) Number | K190783 | K133929 | K160115 | -- | |
| Intended Use | PMS (Mode 1~8)<br>It is intended to stimulate<br>healthy muscles in order to<br>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 | 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 exercise<br>or normal household work<br>activities by applying | The Heat Pain Prois<br>intended for:<br>The relief of pain<br>associated with sore or<br>aching, muscles of the<br>lower back, arms, legs,<br>shoulder, or foot due to<br>strain from exercise or<br>normal household work<br>activities. | SE | |
| Elements of<br>Comparison | | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark |
| | | current to stimulate nerve. | current to stimulate nerve. | | |
| Power Source(s) | | Adaptor Input:<br>100-240Vac, 50-60Hz,<br>0.1A<br>Output: 5Vdc, 2A<br>Unit Input: 5Vdc, 2A | Adaptor Input:<br>100-240Vac, 50-60Hz,<br>0.1A<br>Output: 5Vdc, 1A<br>Unit Input: 5Vdc, 1A | External supply<br>Lithium-ion battery<br>AC adaptor/<br>Rechargeable battery<br>(Lithium Ion) | SE<br>Note 1 |
| -Method of Line<br>Current Isolation | | Type BF Applied Part | Type BF Applied Part | Type BF Applied Part | SE |
| Patient<br>Leakage | NC | AC: 54.5µA, DC: 0.5µA | AC: 54.5µA,<br>DC: 0.5µA | 1 µA | SE |
| Current | SFC | AC:120.0µA, DC: 0.6µA | AC:120.0µA, DC: 0.6µA | 5.25µA max | SE |
| Average DC<br>current through<br>electrodes when<br>device is on but<br>no pulses are<br>being applied | | < 0.01 µA | < 0.01 µA | 0 (uA) | SE |
| Number of<br>Output Channel | | 2 | 2 | 1 | SE |
| Number of Output<br>Modes | | 25 | 25 | -3 Therapies<br>(2 TENS with HEAT<br>combination therapies<br>and 1<br>TENS therapy)<br>-9 TENS Stimulation<br>Modes<br>-2 Heat Level Settings | SE |
| Heating Setting | | Adjustable | -- | High and low | SE<br>Note 3 |
| Heating | | 30-40°C | -- | High: 43 °C maximum | SE |
| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | |
| temperature | | | Low: 42 °C maximum | Note 3 | |
| Output Intensity<br>Level | 99 steps | 99 steps | unknown | SE | |
| Synchronous or<br>Alternating? | Synchronous | Synchronous | unknown | SE | |
| Method of<br>Channel Isolation | Voltage Transform<br>Isolation<br>"Body+" and "Body-"<br>buttons for body channel,<br>" Sole+" and "Sole-"<br>buttons 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 | Regulated Current | SE | |
| Software/Firmwar<br>e/Microprocessor<br>Control? | Yes | Yes | Yes | SE | |
| Automatic<br>Overload Trip | No | No | No | SE | |
| Automatic<br>No-Load Trip | No | No | Yes | SE | |
| Automatic Shut<br>Off | Yes | Yes | Yes | SE | |
| User Override<br>Control | Yes | Yes | Yes | SE | |
| Indicator<br>Display | On/Off<br>Status | Yes | Yes | Yes | SE |
| Elements of<br>Comparison | | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark |
| | Low<br>Battery | No | No | Yes | SE |
| | Voltage/<br>Current<br>Level | Yes | Yes | Yes | SE |
| Timer Range | | 25 to 60 min | 25min | 30 min | SE<br>Note 1 |
| Weight | | 2.1Kg (Without<br>accessories) | 2Kg (Without accessories) | Approx. 200g (incl.<br>batteries) | SE<br>Note 2 |
| Dimensions | | 429.2mm x 401mm x<br>152.8mm | 428mm x 428.8mm x<br>185mm | 71(W)x165(H)x30.5(D)mm | SE<br>Note 2 |
| Housing Materials<br>and Construction | | Main unit: ABS plastic | Main unit: ABS plastic | Unknown | SE |
| Waveform | | Pulsed, symmetric,<br>biphasic | Pulsed, symmetric,<br>biphasic | biphasic | SE |
| Shape | | Rectangular, with<br>interphase interval | Rectangular, with<br>interphase interval | Rectangular | SE |
| Maximum Output<br>Voltage | | 44V±10% @ 500Ω | 44V±10% @ 500Ω | 67.2 V @ 500Ω | SE |
| | | 80V±10% @ 2KΩ | 80V±10% @ 2KΩ | 85.6 V @ 2KΩ | |
| | | 112V±10% @ 10KΩ | 112V±20% @ 10KΩ | 95.9 V @ 10KΩ | |
| Maximum Output<br>Current | | 88mA±10% @ 500Ω | 88mA±10% @ 500Ω | 134.4 mA @ 500Ω | SE |
| | | 40mA±10% @ 2KΩ | 40mA±10% @ 2KΩ | 42.8 mA @ 2KΩ | |
| | | 11.2mA±10% @ 10KΩ | 11.2mA±10% @ 10KΩ | 9.6 mA @ 10KΩ | |
| Pulse Duration | | 120µs | 120µs | 96µs | SE |
| Pulse frequency | | 77.3Hz | 77.3Hz | 1-20.13Hz | SE |
| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | |
| Net Charge (per<br>pulse) | 0µC @ 500Ω<br>Method: Balanced<br>waveform | 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 | 4.3 µC @ 500Ω | SE | |
| Maximum<br>Average Current | 1.63mA @ 500Ω | 0.968mA @ 500Ω | 8.43 mA @ 500Ω | SE | |
| Maximum Current<br>Density<br>(r.m.s ) | 0.0326mA/cm² @ 500Ω | 0.235mA/cm2 @500Ω | 0.08 mA/cm2 @500Ω | SE<br>Note 1 | |
| Maximum<br>Average Power<br>Density | 0.0000266mW/cm² @<br>500Ω | 1.38mW/cm² @ 500Ω | 5.219E-09W/cm² @<br>500Ω | SE<br>Note 1 | |
| ON Time | 240 us | 240 us | 3.00s | SE<br>Note 1 | |
| OFF Time | 12700 us…