Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)

K221251 · Guangzhou Huakai Electronic Technology Co., Ltd. · NUH · Jul 29, 2022 · Neurology

Device Facts

• Record ID: K221251
• Device Name: Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)
• Applicant: Guangzhou Huakai Electronic Technology Co., Ltd.
• Product Code: NUH · Neurology
• Decision Date: Jul 29, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PMS (mode 1~3): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS (mode 4-6): 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. Heating: This function is designed to be used for temporary relief of minor aches and pains.

Device Story

Portable, adapter-powered device providing TENS, PMS, and heating. Inputs: user-selected modes, intensity levels, and time settings via remote controller/main unit. Transforms inputs into electrical pulses delivered through 6 electrode pads (body) or 2 integrated foot pads; heating provided via belt or foot area. Used in home/clinic settings by patients. Output: electrical stimulation and thermal therapy. Healthcare providers/patients use output to manage pain and facilitate muscle performance. Benefits: temporary pain relief and muscle performance improvement. Main unit (ABS plastic) features LCD display, mode/intensity/time controls. Heating range 30-41°C.

Clinical Evidence

Bench testing only. No clinical studies performed. Evidence includes biocompatibility (ISO 10993-5, -10), electrical safety (IEC 60601-1, -11, -2-10), EMC (IEC 60601-1-2), and usability (IEC 62366-1, 60601-1-6).

Technological Characteristics

Materials: ABS plastic housing. Sensing/Actuation: Pulsed, symmetric, biphasic electrical stimulation; resistive heating. Energy: AC adapter (100-240Vac). Connectivity: Standalone. Sterilization: N/A. Software: Microprocessor-controlled, moderate level of concern. Standards: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, ISO 10993.

Indications for Use

Indicated for healthy adults requiring muscle stimulation to improve/facilitate performance (PMS) or temporary relief of pain in shoulder, waist, back, neck, arm, leg, and foot due to exercise or household strain (TENS). Heating function for temporary relief of minor aches and pains.

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

• HIVOX OTC Electrical Stimulator (K203574)
• Health Expert Electronic Stimulator (K190783)

Submission Summary (Full Text)

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July 29, 2022

Guangzhou Hua Kai Electronic Technology Co., Ltd. % Cassie Lee Official Correspondent 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, Guangdong 510000 China

Re: K221251

Trade/Device Name: Ems Foot Stimulator (model: HK701A, HK701A, HK701B, HK701C) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX, IRT Dated: April 21, 2022 Received: May 2, 2022

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/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 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

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# Indications for Use

510(k) Number (if known) K220251

Device Name

Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)

Indications for Use (Describe)

PMS (mode 1~3): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS (mode 4-6): 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.

Heating: This function is designed to be used for temporary relief of minor aches and pains.

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)

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Chapter 6. 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.

#### Submitter's Information 1.

Name: Guangzhou Hua Kai Electronic Technology Co., Ltd. Address: 4th Floor, Building 8, No.39 Bi Gang Road, Donggu Street, Huangpu District Guangzhou, Guangdong, 510730, CHINA Contact name: Cao Ke Title: Manager Tel: [phone] E-mail: [e-mail] Email: [e-mail]

#### Application Correspondent: 2.

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]

#### Subject Device Information 3.

Common Name: Transcutaneous electrical nerve stimulator for pain relief Trade Name: Ems Foot Stimulator Classification Name: Stimulator, Nerve, Transcutaneous, Over-the-Counter Model: HK-701, HK-701A, HK-701B, HK-701C Regulatory Class: II Product Code: NUH, NGX, IRT Regulation Number: 882.5890, 890.5850, 890.5740

#### 2. Predicate Device Information

#### Predicate Device 1:

510(K) Number: K203574

Report by

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Company Name: HIVOX BIOTEK INC.

Address: 5F., No. 123, Xingde Rd., Sanchong Dist., New Taipei City 24158, Taiwan, R.O.C.

Trade Name: Health Expert Electronic Stimulator

Model: EM59-1, EM59-2

Requlation Number: 882.5890, 890.5850, 890.5740

Requlatory Class: II

Product Code: NUH, NGX, IRT

#### Predicate Device 2:

510(K) Number: K190783 Company Name: Shenzhen OSTO Technology Company Limited Address: No.43 Longfeng Road, Xinsheng Community, Longgang Street, Longgang District, Shenzhen City, Guangdong Province, China Trade Name: Health Expert Electronic Stimulator Model: AST-300L Common Name: Electronic Stimulator Regulation Number: 882.5890 Requlatory Class: II Product Code: NUH, NGX

### 3. Device Description

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

Ems Foot Stimulator has 6 modes (PMS mode 1~3, TENS mode 4~6), which can give certain electrical pulse through 6 pcs of electrode Pad placed on the body to help users to enjoy body stimulation. There are 2 big electrode pads in foot conductive area for feet placed on the main unit to help users to enjoy sole stimulation. And a heating belt can provide heating treatment on waist area.

The main unit has the operating elements of Power on/off switch, ON/OFF Switch, Display screen, 2 Mode Selection keys, 2 Intensity Selection keys and a time setting key.

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

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| Sponsor: | Guangzhou Hua Kai Electronic Technology Co., Ltd. |
|-----------------|---------------------------------------------------|
| Subject Device: | EMS Foot Massager |
| File No.: | 510(k) submission report (V1.0) |

The remote controller has a ON/OFF Switch to control the EMS/ TENS treatment, a ON/OFF switch to control heating treatment, 2 mode selection keys, 2 intensity selection keys, 2 heating adjust keys and a time setting key.

The heating belt and foot conductive pad can only warm the waist and foot rang 30 to 41 ˚C The Heating adjust keys on remote controller can help user to adjust the temperature for warming the waist and foot simultaneously. The heating time is same as the treatment time you selected. The heating and stimulation can be applied simultaneously.

There are 4 models, model HK701, HK701A, and HK701C, all the four models include a main unit and many accessories. The main unit of the four models are the same, the difference is only the accessories included in the package, so the function is a little different. Model difference is as below:

| Item | HK701 | HK701A | HK701B | HK701C |
|--------------|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------|-----------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Function | Stimulation on<br>foot and body,<br>heating on foot<br>and waist. | Stimulation on<br>foot, heating on<br>foot. | Stimulation on<br>foot, heating on<br>waist. | Stimulation on<br>foot and body,<br>heating on foot. |
| Accessories. | 3 pairs of<br>electrode pads,<br>a heating belt,<br>an adapter, 2<br>electrode wire,<br>a remote<br>controller. | An adapter, a<br>remote<br>controller. | A heating belt,<br>an adapter,<br>a remote<br>controller. | 3 pairs of<br>electrode pads,<br>an adapter, 2<br>electrode wire, a<br>remote controller. |

### 4. Intended Use / Indications for Use

PMS (mode 1~3): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS (mode 4~6): 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. Heating: This function is designed to be used for temporary relief of minor aches and pains.

#### 5. Performance data and test summary

The following performance data were provided in support of the substantial equivalence determination.

#### Nonclinical test performed

1) Biocompatibility testing

The biocompatibility evaluation for the Ems Foot Stimulator was conducted in accordance with "Use of International SO 10993-1, "Biological evaluation of medical devices -

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| Sponsor: | Guangzhou Hua Kai Electronic Technology Co., Ltd. |
|-----------------|---------------------------------------------------|
| Subject Device: | EMS Foot Massager |
| File No.: | 510(k) submission report (V1.0) |

Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatibility testing included the following tests:

- . Cytotoxicity
- . Sensitization
- Irritation .

According to the test results, the subject device is biocompatible for its intended use. And it is complied with biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 Irritation and Sensitization).

2) Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Ems Foot Stimulator, the device complies with the IEC 60601-1, IEC 60601-1-11, and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC.

3) Usability Testing

Usability testing were conducted on the Ems Foot Stimulator, the device complies with IEC 62366-1 and IEC 60601-1-6.

4) Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a malfunction of, or a latent design flaw in, the Software Device lead s to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.

## Clinical performance testing performed

No clinical study was performed.

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## 6. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of Ems Foot 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.

### Comparison in Detail(s):

| Elements of<br>Comparison | Subject Device | Primary Predicate<br>Device | Secondary<br>Predicate<br>Device | Remark | |
|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------------|
| Device Name<br>and Model | Ems Foot Stimulator<br>Model: 701, 701A,<br>701B, 701C | HIVOX OTC Electrical<br>Stimulator<br>Model: EM59-1, EM59-2 | Health Expert<br>Electronic<br>Stimulator<br>Model: AST-300L | -- | |
| 510(k) Number | Applying | K203574 | K190783 | -- | |
| Product Code | NUH, NGX, IRT | NUH, NGX, IRT | NUH, NGX | Same | |
| Intended Use | PMS (mode 1~3): It is<br>intended to stimulate<br>healthy muscles in<br>order to improve and<br>facilitate muscle<br>performance.<br>TENS (mode 4~6): To<br>be used for temporary<br>relief of pain<br>associated with sore<br>and aching muscles in<br>the shoulder, waist,<br>back, back of the neck,<br>arm, leg, and foot due<br>to strain from exercise<br>or normal household<br>work activities by<br>applying current to<br>stimulate nerve.<br>Heating: This function<br>is designed to be used<br>for temporary relief of<br>minor aches and<br>pains. | HIVOX OTC Electrical<br>Stimulator, EM59-2<br>TENS: This function is<br>designated to be used for<br>temporary relief of pain<br>associated with sore and<br>aching muscles in the<br>shoulder, waist, back,<br>upper extremities (arm)<br>and lower extremities (leg)<br>due to strain from<br>exercise or normal<br>household<br>work activities.<br>EMS: This function is<br>designed to be used for<br>stimulating healthy<br>muscles in order to<br>improve and facilitate<br>muscle<br>performance.<br>SH: This function is<br>designed to be used for<br>temporary relief of minor<br>aches and pains. | PMS (Mode 1~8)<br>It is intended to<br>stimulate healthy<br>muscles in order to<br>improve and<br>facilitate muscle<br>performance.<br>TENS (Mode 9~25)<br>To be used for<br>temporary relief of<br>pain associated with<br>sore and aching<br>muscles in the<br>shoulder, waist,<br>back, back of the<br>neck, arm, leg, and<br>foot due to strain<br>from exercise or<br>normal household<br>work activities by<br>applying current to<br>stimulate nerve. | Same | |
| Elements of<br>Comparison | | Subject Device | Primary Predicate<br>Device | Secondary<br>Predicate<br>Device | Remark |
| Power<br>Source(s) | | Adaptor Input: 100-<br>240Vac, 50-60Hz,<br>0.1A<br>Output: DC12V-3A | Rechargeable battery | Adaptor Input:<br>100-240Vac, 50-<br>60Hz,<br>0.1A<br>Output: 5Vdc, 2A<br>Unit Input: 5Vdc, 2A | Similar<br>Note 1 |
| Function and<br>Design | | Electrical stimulation<br>and heat | Electrical stimulation and<br>heat | Electrical<br>stimulation and heat | Same |
| Heating Setting | | Adjustable | Low and high | Adjustable | Same |
| Output Patterns | | ● Electrical<br>stimulation only<br>● Heat only<br>● Electrical<br>stimulation + heat<br>simultaneously | ● Electrical stimulation<br>only<br>● Heat only<br>● Electrical stimulation<br>+ heat<br>simultaneously | Not public available | Same |
| Method of Line<br>Current<br>Isolation | | Type BF Applied Part | N/A (internal power<br>source) | Type BF Applied<br>Part | Same |
| Patient<br>Leakage<br>Current | NC<br>SFC | AC: 54.5μA, DC:<br>0.5μA<br>AC:120.0μA, DC:<br>0.6μA | 6.0 μΑ<br>5.6 μΑ | AC: 54.5μA, DC:<br>0.5μA<br>AC:120.0μA, DC:<br>0.6μA | Same |
| Average DC<br>current through<br>electrodes when<br>device is on but<br>no pulses are<br>being applied | | < 0.01μA | Not public available | < 0.01μA | Same |
| Number of<br>Output Channel | | 2 | 2 | 2 | Same |
| Number of<br>Output Modes | | 6 | Model EM 59-2:<br>TENS: 15<br>EMS: 35 | 25 | Similar<br>Note 2 |
| Elements of<br>Comparison | Subject Device | Primary Predicate<br>Device | Secondary<br>Predicate<br>Device | Remark | |
| | 30-41°C | SH: 1<br>Maximum temperature<br>setting 43°C | 30-40°C | Similar<br>Note 2 | |
| Output Intensity<br>Level | TENS: 99 steps<br>EMS: 99 steps<br>Heating: 6 levels | TENS: level 0 to 50<br>EMS: Level 0 to 50<br>SH: Level LOW to HI | 99 steps | Similar<br>Note 2 | |
| Synchronous or<br>Alternating? | Synchronous | Synchronous | Synchronous | Same | |
| Method of<br>Channel<br>Isolation | By electrical circuit and<br>software | By electrical circuit and<br>software | Voltage Transform<br>Isolation<br>"Body+" and "Body-"<br>buttons for body<br>channel, "Sole+"<br>and "Sole-" buttons<br>for feet channel | Same | |
| Regulated<br>Current or<br>Regulated<br>Voltage? | Voltage Control | Regulated current | Voltage Control | Same | |
| Software/Firmw<br>are/Microproces<br>sor Control? | Yes | Yes | Yes | Same | |
| Automatic<br>Overload Trip | No | Yes | No | Same | |
| Automatic No-<br>Load Trip | No | Yes | No | Same | |
| Automatic Shut<br>Off | Yes | Yes | Yes | Same | |
| User Override<br>Control | Yes | Yes | Yes | Same | |
| Indicator<br>Display | On/Off<br>Status | Yes | Yes | Yes | Same |
| | Low<br>Battery | No | Yes | No | Same |
| Elements of<br>Comparison | Subject Device | Primary Predicate<br>Device | Secondary<br>Predicate<br>Device | Remark | |
| Voltage/<br>Current Level | Yes | Yes | Yes | Same | |
| Timer Range | 15min, 20min, 25min,<br>30min | 5 to 100 minutes<br>adjustable | 25 to 60 min | Similar<br>Note 2 | |
| Weight | 2.28Kg (Without<br>accessories) | Approx. 125 (including<br>belt clip and battery) | 2.1Kg (Without<br>accessories) | Different<br>Note 3 | |
| Dimensions | 41 x 40 x 13cm | Approx. 139 x 66 x26<br>(including belt clip) | 429.2mm x 401mm<br>x 152.8mm | Different<br>Note 3 | |
| Housing<br>Materials and<br>Construction | Main unit: ABS plastic | Plastic (ABS) enclosure | Main unit: ABS<br>plastic | Same | |
| Waveform | Pulsed, symmetric,<br>biphasic | Biphasic…