Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator

K233054 · Well-Life Healthcare Limited · NUH · Oct 18, 2024 · Neurology

Device Facts

• Record ID: K233054
• Device Name: Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator
• Applicant: Well-Life Healthcare Limited
• Product Code: NUH · Neurology
• Decision Date: Oct 18, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The WL-2315C(M) and WL-2315E(M) are designed for the symptomatic relief and management of pain. They offer temporary relief from pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication. The WL-2405H(M) is designed for symptomatic relief and management of chronic pain and provides temporary relief from sore and aching muscles in the shoulders, waist, back, neck, upper extremities (arms), and lower extremities (legs) due to strain from exercise or daily activities. It also offers temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication. Additionally, the WL-2405H(M) features EMS functionality for stimulating healthy muscles to enhance or facilitate muscle performance (select EMS modes). It also provides symptomatic relief and management of chronic, intractable pain and relief from pain associated with arthritis (select TENS mode P8).

Device Story

Transcutaneous electrical nerve stimulator (TENS) and electrical muscle stimulator (EMS) for pain management and muscle performance; inputs include user-selected preset modes, intensity levels, and treatment duration via interface; device delivers electrical pulses to skin via electrode pads or garment electrodes; operates via 3.7V lithium-ion battery; used by adults in home/daily settings; output signals (TENS/EMS) provide symptomatic relief for chronic/intractable pain, arthritis, dysmenorrhea, and muscle strain; healthcare providers/patients use output to manage pain and facilitate muscle performance; benefits include non-pharmacological pain relief and muscle stimulation.

Clinical Evidence

No clinical performance testing was conducted or necessary for this device and indications for use. Bench testing was performed to verify output parameter specifications per AAMI NS4(2013) and electrical safety/EMC per IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-10.

Technological Characteristics

Battery-powered (3.7V Li-ion) electrical stimulator; provides TENS and EMS modes; features LCD/LED display, 1-2 output channels, and user-adjustable intensity/duration; uses asymmetrical square pulse waveforms; compliant with IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-10, and AAMI NS4; intended for use with cleared electrode pads (K082065) and garment electrodes (K200942).

Indications for Use

Indicated for adult patients for symptomatic relief and management of chronic pain, chronic intractable pain, arthritis-related pain, and pain associated with dysmenorrhea (menstrual cramps) when used with OTC pain medication. Also indicated for temporary relief of sore/aching muscles in shoulders, waist, back, neck, arms, and legs due to strain from exercise or daily activities, and for stimulation of healthy muscles to enhance or facilitate muscle performance.

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

• OTC Combo TENS/EMS System (K172809)
• Livia (K183110)

Reference Devices

• WELL LIFE SELF ADHESIVE ELECTRODE (K082065)
• Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series) (K220524)

Submission Summary (Full Text)

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October 18, 2024

Well-Life Healthcare Limited Jenny Hsieh Official Correspondent 6F., No. 168, Lide St., Jhonghe District New Taipei City, Taiwan 235

#### Re: K233054

Trade/Device Name: Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator: TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator Regulation Number: 21 CFR 882.5890, 21 CFR 890.5850 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX, NYN Dated: September 2, 2024 Received: September 18, 2024

Dear Jenny Hsieh:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

# Robert Kang -S

for 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) K233054

#### Device Name

Well-Life Pain Relief (Menstrual Stimulator: TENS/EMS WITH Menstrual Relief Stimulator: Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator

#### Indications for Use (Describe)

For WL-2315C(M) and WL-2315E(M) models:

The WL-2315C(M) and WL-2315E(M) are designed for the symptomatic relief and management of pain. They offer temporary relief from pain associated with dysmenorrhea (menstrual cramps) when used with over-the- counter pain medication.

For WL-2405H(M) model:

The WL-2405H(M) is designed for symptomatic relief and management of chronic pain and provides temporary relief from sore and aching muscles in the shoulders, waist, back, upper extremities (arms), and lower extremities (legs) due to strain from exercise or daily activities. It also offers temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication.

Additionally, the WL-2405H(M) features EMS functionality for stimulating healthy muscles to enhance or facilitate muscle performance (select EMS modes). It also provides symptomatic relief and management of chronic, intractable pain and relief from pain associated with arthritis (select TENS mode P8).

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | <div style="display:inline-block;">☐</div> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div style="display:inline-block;">☑</div> |

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Image /page/4/Picture/0 description: The image shows a logo for "well-life" with the tagline "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING." The logo features a stylized yellow butterfly shape, with the word "well-life" superimposed on the butterfly's wing. The tagline is written in smaller letters below the company name.

# Well-Life Healthcare Limited 510(K) Statement

| 1. | Type of Submission: | Traditional |
|----|----------------------|---------------------------------------------------------------------------|
| 2. | Preparation date: | 10/17/2024 |
| 3. | Submitter: | Well-Life Healthcare Ltd. |
| | Address: | 6F. No.168, Lide St., Jhonghe District, New Taipei City,<br>23512, Taiwan |
| | Phone: | [phone] |
| | Fax: | [phone] |
| | Contact: | Jenny Hsieh<br>([e-mail]) |
| | Registration number: | 3006850006 |

#### 1. Identification of the device:

| 510(K) No | K233054 |
|-------------------------|----------------------------------------------------------------------|
| Subject Device Name: | Well-Life Pain relief (Menstrual Plus) Electrical<br>Stimulator |
| Common or usual name: | Electrical stimulator, Transcutaneous electrical nerve<br>stimulator |
| Model: | WL-2405H (M), WL-2315C (M), WL-2315E (M) |
| Classification name: | stimulator, nerve, transcutaneous, over-the-counter |
| Classification Panel: | Neurology |
| Device Classification: | II |
| OTC/RX | OTC |
| Regulation Number: | 21 CFR Part 882.5890 |
| Primary Product Code | NUH |
| Secondary product codes | NGX, NYN |

#### 2. Identification of the Predicate Devices:

| Primary Predicate Device: | |
|---------------------------|-----------------------------------------------------|
| 510(K) No | K172809 |
| Device Name: | OTC Combo TENS/EMS System |
| Model: | WL-2405H, WL-2405(G) |
| Classification name: | stimulator, nerve, transcutaneous, over-the-counter |
| Classification Panel: | Neurology |
| Device Classification: | II |
| OTC/RX | OTC |
| Regulation Number: | 21 CFR Part 882.5890 |
| Product Code | NUH, NGX, NYN |

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Image /page/5/Picture/0 description: The image shows the logo for Well-Life. The logo features a yellow butterfly with the words "well-life" written in blue on the butterfly's wing. Below the company name is the text "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING".

| Secondary Predicate Device: | |
|-----------------------------|-----------------------------------------------------|
| 510(K) No | K183110 |
| Device Name: | Livia |
| Model: | -- |
| Classification name: | stimulator, nerve, transcutaneous, over-the-counter |
| Classification Panel: | Neurology |
| Device Classification: | II |
| OTC/RX | OTC |
| Regulation Number: | 21 CFR Part 882.5890 |
| Product Code | NUH |

| Reference Device 1: Accessories | | |
|---------------------------------|-----------------------------------|--|
| 510(K) No | K082065 | |
| Device Name: | WELL LIFE SELF ADHESIVE ELECTRODE | |
| Model: | CM, FA, PU AND SP | |
| Classification name: | Electrode, Cutaneous | |
| Classification Panel: | Neurology | |
| Device Classification: | II | |
| OTC/RX | OTC+RX | |
| Regulation Number: | 21 CFR Part 882.1320 | |
| Product Code | GXY | |

| Reference Device 2: Reference | |
|-------------------------------|--------------------------------------------------------------|
| 510(K) No | K220524 |
| Device Name | Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE<br>Series) |
| Model: | WL-2301E/WL-2301C |
| Classification name: | Stimulator, Nerve, Transcutaneous, Over-the-Counter |
| Classification Panel: | Neurology |
| Device Classification: | II |
| OTC/RX | OTC |
| Regulation Number: | 882.5890 |
| Product Code | NUH |

3. Indications for use of the Subject Device:

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Image /page/6/Picture/0 description: The image shows a logo for "well-life". The logo features a yellow butterfly with the text "well-life" in blue on the right side of the butterfly. Below the text is the phrase "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in smaller, dark text.

#### Indications for use

Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator The Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator includes three models: WL-2315C(M), WL-2315E(M), and WL-2405H(M). The indications for use are as follows:

#### For WL-2315C(M) and WL-2315E(M)

The WL-2315C(M) and WL-2315E(M) are designed for the symptomatic relief and management of pain. They offer temporary relief from pain associated with dysmenorrhea (menstrual cramps) when used with over-the- counter pain medication.

#### For WL-2405H(M)

The WL-2405H(M) is designed for symptomatic relief and management of chronic pain and provides temporary relief from sore and aching muscles in the shoulders, waist, back, neck, upper extremities (arms), and lower extremities (legs) due to strain from exercise or daily activities. It also offers temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication.

Additionally, the WL-2405H(M) features EMS functionality for stimulating healthy muscles to enhance or facilitate muscle performance (select EMS modes). It also provides symptomatic relief and management of chronic, intractable pain and relief from pain associated with arthritis (select TENS mode P8).

#### 4. Description of the Device:

The Well-Life Pain relief (Menstrual Plus) Electrical Stimulator is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower (extremities) leg due to strain from exercise or normal household work activities. It also provides symptomatic relief and management of chronic, intractable pain and relief from pain associated with arthritis This stimulator should be applied to the normal, healthy, dry, and clean skin of adult patients with the aim of stimulating healthy muscles and enhancing muscle performance.

There are three available models: WL-2405H(M), WL-2315E(M), and WL-2315C(M). WL-2405H(M) is derived from the WL-2405H (FDA 510K no. K172809) with modifications. It includes the original TENS modes P1-P8 and EMS modes P1-P6, along with two additional TENS modes (P9, P10). TENS P9 is used for Pain Relief/Menstrual pain relief, while TENS P10 is suitable for Pain Relief. The WL-2405H(M) model offers 16 preset modes, with 10 modes for TENS (Transcutaneous Electrical Nerve Stimulation) and 6 modes for EMS (Electrical Muscle Stimulation). It features an LCD/LED display and a user-friendly interface that allows for adjustments to preset modes, output signal intensity, and treatment duration. It also includes two output channels.

The WL-2315E(M)/WL-2315C(M) model is a distinct version that exclusively focuses on the TENS P9 mode for dysmenorrhea pain relief, derived from the WL-2405H(M) model. This series of products is an adaptation of the mini-TENS stimulator.

(wl-23xxc/wl-23xxe series) family (FDA 510K no. K220524), with identical external design and internal components, software, etc., with the only modification being the Output Signal. This model has three buttons for power on/off and intensity adjustment and is intended for use with the specified preset mode, providing relief for chronic pain and sore muscles in various body areas. It is for alleviating pain associated with dysmenorrhea (menstrual cramps).

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Image /page/7/Picture/0 description: The image shows the logo for Well-life, a healthcare products company. The logo features a yellow butterfly shape on the left side. The company name "well-life" is written in blue text to the right of the butterfly. Below the company name, the tagline "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" is written in smaller blue text.

The Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator must be used with 510K cleared Electrode pads (K082065) and Garment electrodes (K200942). These accessories are available for purchase along with the device or separately as supplementary packs.

#### 5. Non-Clinical Performance Testing:

Non-clinical testing was conducted to verify that the subject devices met all design specifications, demonstrated safety based on current industry standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed:

- 1) Sterilization and Shelf Life
To demonstrate the adequacy of the shelf life, the recommended study process for the similar product released on guidance document FDA-2020-D-0957 "Shelf Life of Medical Devices" and ASTM F1980-16 "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices "is followed. After test and study, the shelf life for electrodes to be used with the device is 2 years.

- 2) Biocompatibility
No biocompatibility testing performed for this submission because to be used with the device have already been cleared in K082065 and K200942.

- 3) Software Validation
The FDA guidance document titled "General Principles of Software Validation: Final Guidance for Industry and FDA Staff"issued on 11/05/2005" was used to validate software used in the device. Required documentation was provided in accordance with this guidance document.

- 4) Electromagnetic compatibility and electrical safety
Testing was performed to verify the electromagnetic compatibility and electrical safety of the subject device using the following standards:

- (1) IEC60601-1: General requirements for basic safety and essential performance
(2) IEC-60601-1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

(3) IEC-60601-1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

(4) IEC-60601-2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

(5) Bench testing was performed to verify the output parameter specifications of the device using the AAMI NS4(2013) standard for Transcutaneous Electrical Nerve Stimulators

#### 5) Clinical Testing Performance Testing

No clinical performance testing was conducted or necessary for this device and indications for use.

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Image /page/8/Picture/0 description: The image shows the logo for "well-life", a company that produces healthcare products. The logo features a yellow butterfly with the company name written in blue text. Below the company name is the tagline "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in smaller, blue text. The logo is simple and clean, and the butterfly is a symbol of transformation and hope.

#### 7. Substantial Equivalence Discussion:

#### 7.1 Substantial Equivalence Comparison to Predicate Device

| Attribute | Subject Device | Primary Predicate Device: | Secondary Predicate Device: | Comparison |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Name | The Well-Life Pain relief<br>(Menstrual Plus) Electrical<br>Stimulator | OTC Combo TENS/EMS<br>System | Livia | |
| Model | WL-2405H(M), WL-2315E(M),<br>WL-2315C(M) | WL-2405H, WL-2405G | --- | |
| Manufacture | Well-life Healthcare | Well-life Healthcare | Life-Care Ltd. | |
| 510(K) number | Applying | K172809 | K183110 | |
| Product Code | NUH, NGX, NYN | NUH, NGX, NYN | NUH | Identical |
| Regulation No. | 882.5890 | 882.5890 | 882.5890 | Identical |
| Main function | 1. TENS<br>General Pain/ Menstrual pain<br>relief/for WL-2405H(M)<br>2. EMS | 1. TENS<br>(General Pain/)<br>2. EMS | TENS<br>(General Pain/ Menstrual pain<br>relief) | Note. 1 |
| Indications for Use | The Well-Life Pain Relief<br>(Menstrual Plus) Electrical<br>Stimulator includes three<br>models: WL- 2315C(M),<br>WL-2315E(M), and<br>WL-2405H(M). The<br>indications for use are as<br>follows:<br><br>For WL-2315C(M) and WL-<br>2315E(M) | For temporary relief of pain associated<br>with sore and aching muscles in the<br>lower back due to strain from exercise<br>or<br>normal household and work activities.<br>(Choose TENS Modes P1 through P7)<br>For temporary relief of pain associated<br>with sore and aching muscles in the<br>upper and lower extremities (arm<br>and/or leg) due to strain from exercise<br>or normal household and work | The Livia is designed for<br>symptomatic relief and<br>management of chronic pain,<br>and for temporary relief of<br>pain associated with sore and aching<br>muscles in the shoulder, waist, back,<br>neck, upper extremities (arm) and<br>lower (extremities) leg due to strain<br>from exercise or normal household<br>work activities and for temporary relief<br>of pain associated with dysmenorrhea<br>(menstrual cramps) when used with<br>OTC pain medication | |

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Image /page/9/Picture/0 description: The image shows a logo for "well-life" with the tagline "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING". The logo features the text "well-life" in a stylized font, with the word "well" stacked above "life". To the left of the text is a yellow butterfly. The tagline is written in smaller letters below the company name.

| The WL-2315C(M) and WL-<br>2315E(M) are designed for the<br>symptomatic relief and<br>management of pain. They<br>offer temporary relief from<br>pain associated with<br>dysmenorrhea (menstrual<br>cramps) when used with over-<br>the- counter pain medication.<br><br>For WL-2405H(M)<br><br>The WL-2405H(M) is designed<br>for symptomatic relief and<br>management of chronic pain<br>and provides temporary relief<br>from sore and aching muscles<br>in the shoulders, waist, back,<br>neck, upper extremities (arms),<br>and lower extremities (legs) due<br>to strain from exercise or daily<br>activities. It also offers<br>temporary relief of pain<br>associated with dysmenorrhea<br>(menstrual cramps) when used<br>with over-the-counter pain<br>medication.<br>Additionally, the WL-<br>2405H(M) features EMS<br>functionality for stimulating<br>healthy muscles to enhance or<br>facilitate muscle performance<br>(select EMS modes). It also<br>provides symptomatic relief and | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| management of chronic,<br>intractable pain and relief from<br>pain associated with arthritis<br>(select TENS mode P8). | | |

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Image /page/10/Picture/0 description: The image shows the logo for Well-life. The logo features a yellow butterfly with the words "well-life" in blue text over the butterfly. Below the company name is the text "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING".

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Image /page/11/Picture/0 description: The image shows the logo for Well-Life. The logo features a yellow butterfly with the words "well-life" in blue text superimposed on the butterfly's wing. Below the company name is the text "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in smaller, black font.

| Attribute | Subject Device | Primary Predicate Device: | Secondary Predicate Device: | Comparison |
|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| | | activities. (Choose TENS Modes P1<br>through P7)<br>For symptomatic relief and<br>management of chronic, intractable<br>pain and relief of pain associated with<br>arthritis. (Choose<br>TENS Mode P8)<br>For use by healthy adults for the<br>stimulation of healthy muscles in order<br>to improve or facilitate muscle<br>performance.<br>(Choose EMS Modes P1 through P6 | | |
| Prescriptive or OTC | OTC | OTC | OTC | Identical |
| Number of output modes | WL-2315E(M), WL-2315C(M)<br>1 mode for TENS<br>WL-2405H(M)<br>TENS: 10+EMS: 6 | TENS: 8<br>EMS: 6 | 1 | Note. 2 |
| Power Source(s) | 3.7V Lithium-Ion Battery | 3.7V Lithium-Ion Battery | 3.7V Lithium-Ion Battery | Identical |
| Method of Line Current<br>Isolation | Output is electrically disabled<br>when connect to charger, by<br>Output is electrically disabled<br>when connect to charger, by<br>Identical 4-6 means of<br>microprocessor charging circuit | Output is electrically disabled<br>when connect to charger, by<br>Output is electrically disabled<br>when connect to charger, by<br>Identical 4-6 means of<br>microprocessor charging circuit | Output is electrically disabled<br>when connect to charger, by<br>Output is electrically disabled<br>when connect to charger, by<br>Identical 4-6 means of<br>microprocessor charging circuit | Identical |
| Patient Leakage Current<br>- Normal Condition (μΑ) | Battery powered (< 10μA) | Battery powered (< 10μA) | Battery powered (< 10μA) | Identical |
| Patient Leakage Current | Battery powered (< 50μA) | Battery powered (< 50μA) | Battery powered (< 50μA) | Identical |
| Attribute | Subject Device | Primary Predicate Device: | Secondary Predicate Device: | Comparison |
| - Single Fault Condition<br>(μΑ) | | | | |
| Average DC current<br>through Electrodes when<br>device is on but no pulses<br>are being applied (µA) | 0 μΑ | 0 μΑ | 0 μΑ | Identical |
| Regulated Current or<br>Regulated Voltage | Current | Current | Current | Identical |
| Software/Firmware/Micro<br>processor<br>Control | Yes | Yes | Yes | Identical |
| Automatic Overload Trip | Yes | Yes | Yes | Identical |
| Automatic No-Load Trip | Yes | Yes | Yes | Identical |
| Automatic Shut Off | Yes | Yes | Yes | Identical |
| User Override Control | Yes | Yes | Yes | Identical |
| Indicator Display:<br>On/Off Status/Low<br>Battery/Voltage/Current<br>Level | Yes | Yes | Yes | Identical |
| Number of output<br>channels | WL-2405H(M): 2<br>WL-2315E(M)/WL-2315C(M):<br>1 | 2 | 1 | Identical |
| Automatic no-load trip | Yes | Yes | Yes | Identical |
| Attribute | Subject Device | Primary Predicate Device: | Secondary Predicate Device: | Comparison |
| Patient override control<br>method | Yes | Yes | Yes | Identical |
| Maximum output voltage | WL-2405H(M): 40V @500 ohm<br>WL-2315E(M): 30V @500 ohm | 40V @500 ohm | 65.6 V @500 ohm<br>121V @2K ohm<br>130.4V @10K ohm | Similar<br>Note. 3 |
| Maximum output current | WL-2405H(M): 80mA<br>@500 ohm<br>WL-2315E(M):<br>60mA@500 ohm | 80mA@500 ohm | 130.4 mA @500 ohm | Similar<br>Note. 3 |
| Pulse width | TENS 2-245 us<br>EMS 4-99 us | TENS 2-245 us<br>EMS 4-99 us | 100 us | Similar<br>Note. 3 |
| Frequency | TENS 100-260 Hz<br>EMS 200-300 Hz | TENS 156-260 Hz<br>EMS 200-300 Hz | 100 Hz | Similar<br>Note. 3 |
| Accessories | Default accessories<br>Electrode Pads (K082065)<br>Optional accessories<br>Garment electrodes (K200942) | Electrode Pads (K082065) | Electrode Pads | Similar<br>Note. 4 |
| Compliance with<br>voluntary standard | 60601-1<br>60601-1-2<br>60601-1-11<br>60601-2-10 | 60601-1<br>60601-1-2<br>60601-1-11<br>60601-2-10 | 60601-1<br>60601-1-2<br>60601-1-11<br>60601-2-10 | Identical |

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Image /page/12/Picture/0 description: The image shows the logo for Well-life. The logo features a yellow butterfly on the left side. To the right of the butterfly, the words "well-life" are written in a blue, cursive font. Below the company name, the words "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" are written in smaller, red font.

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Image /page/13/Picture/0 description: The image shows a logo for "well-life". The logo features a yellow butterfly with the words "well-life" in blue text superimposed on the butterfly's wing. Below the company name is the text "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING".

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Image /page/14/Picture/0 description: The image shows the logo for Well-Life. The logo features a yellow butterfly with the words "well-life" in blue on the butterfly's wing. Below the company name is the text "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in a smaller font.

#### 7.2 Intra Comparison

| | WL-2405H / K172809<br>(Primary Predicate Device) | WL-2405H(M)<br>(Applying) | Comparison |
|-------------------|--------------------------------------------------|------------------------------|-------------------|
| Channel | 2 | 2 | Identical |
| Level | 0-25 Digital | 0-25 Digital | Identical |
| Max Voltage | 40 (Vpp @ 500 ohm) | 40 (Vpp @ 500 ohm) | Identical |
| Max current | 80mA Max | 80mA Max | Identical |
| Power indicator | LCD+LED Backlight | LCD+LED Backlight | Identical |
| Timer | 5-60 min | 5-60 min | Identical |
| Power source | 3.7V Li-Rechargeable battery | 3.7V Li-Rechargeable battery | Identical |
| Waveform | Asymmetrical square pulse | Asymmetrical square pulse | Identical |
| Frequency range | TENS 2-245<br>EMS 4-99 | TENS 2-245<br>EMS 4-99 | Identical |
| Pulse Width range | TENS 156-260<br>EMS 200-300 | TENS 100-260<br>EMS 200-300 | Similar<br>Note.3 |
| Preset Mode | TENS:8Modes<br>EMS:6Modes | TENS: 10Modes<br>EMS:6Modes | Similar<br>Note.3 |

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Image /page/15/Picture/0 description: The image shows the logo for Well-Life. The logo features a yellow butterfly with the words "well-life" written in blue on the butterfly's wing. Below the company name is the text "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING".

| | WL-2306E<br>K220524<br>(Reference Device 2) | /<br>WL-2315E(M)<br>(Applying) | /<br>WL-2306C<br>K220524<br>(Reference Device 2) | /<br>WL-2315C(M)<br>(Applying) | Comparison |
|-----------------------------------|---------------------------------------------|-------------------------------------|--------------------------------------------------|-------------------------------------|-------------------|
| Channel | 1 | 1 | 1 | 1 | Identical |
| Level | 0~10 Digital | 0~10 Digital | 0~10 Digital | 0~10 Digital | Identical |
| Max Voltage | 30V<br>(Vpp @ 500 ohm) | 30V<br>(Vpp @ 500 ohm) | 30V<br>(Vpp @ 500 ohm) | 30V<br>(Vpp @ 500 ohm) | Identical |
| Max current | 60mA Max | 60mA Max | 60mA Max | 60mA Max | Identical |
| Power indicator | LED indicator | LED indicator | LED indicator | LED indicator | Identical |
| Timer | 20 min | 20 min | 20 min | 20 min | Identical |
| Power source | 3.7V<br>Li-<br>Rechargeable battery | 3.7V<br>Li-<br>Rechargeable battery | 3.7V<br>Li-<br>Rechargeable battery | 3.7V<br>Li-<br>Rechargeable battery | Identical |
| Waveform | Asymmetrical square<br>pulse | Asymmetrical square<br>pulse | Asymmetrical square<br>pulse | Asymmetrical square<br>pulse | Identical |
| Frequency range (Hz) | 15-120 | 100 | 15-120 | 100 | Similar<br>Note.3 |
| Width<br>Pulse<br>range<br>(uSec) | 150-260 | 100 | 150-260 | 100 | Similar<br>Note.3 |
| Preset Mode | 1 mode for TENS | 1 mode for TENS | 1 mode for TENS | 1 mode for TENS | Identical |

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Image /page/16/Picture/0 description: The image contains the logo for Well-Life Healthcare Limited. The logo features the words "well-life" in a stylized font, with a butterfly graphic behind the text. Below the logo is the text "Well-Life Healthcare Limited" in a larger, bolder font.

#### 7.3 Output Parameter Specifications by Mode

| WL-2405H(M) | | | | |
|-------------|-------------|-----------|-------------------------------|------------------------------------|
| Mode | Pulse width | Frequency | Duty Time<br>Up-Hold-Down-OFF | Suggested Uses |
| TENS P1 | 260 | 15 | Continual | Pain Relief |
| TENS P2 | 260 | 60 | Continual | Pain Relief |
| TENS P3 | 260 | 60 | Continual | Pain Relief |
| TENS P4 | 260-156 | 2-60 | Continual | Pain Relief |
| TENS P5 | 260-156 | 60 | Continual | Pain Relief |
| TENS P6 | 260 | 7-60 | Continual | Pain Relief |
| TENS P7 | 260-156 | 60 | Continual | Pain Relief |
| TENS P8 | 210 | 2.45-245 | Continual | Pain Relief /Arthritis |
| TENS P9 | 100 | 100 | Continual | Pain Relief /Menstrual pain relief |
| TENS P10 | 100 | 80/8 | Continual | Pain Relief |
| EMS P1 | 300 | 40-99 | x-2-x-1 | Warm up |
| EMS P2 | 200 | 4 | Continual | Recovery |
| EMS P3 | 300 | 5 | Continual | Recovery |
| EMS P4 | 200 | 99 | x-2-x-1 | Recovery |
| EMS P5 | 200 | 4-20 | 2-6-2-1 | Endurance |
| EMS P6 | 300 | 50 | 2-5-3-10 | Performance |

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Image /page/17/Picture/0 description: The image shows the logo for Well-Life. The logo features a yellow butterfly with the words "well-life" in blue text on top of the butterfly. Below the butterfly, the words "Smarter Healthcare Products for Better Living" are written in smaller, black text.

| WL-2315E(M)/WL-2315C(M) | | | | | | | | | |
|-----------------------------|-------------|------------------|-------------------------------|---------------------------------------|----------------------------|---------------------------------|-------------------------|------------------------------------------------|-------------------------------------------------|
| Mode | Pulse width | Frequency | Duty Time<br>Up-Hold-Down-OFF | Indications | | | | | |
| Default (TENS P9) | 100 | 100 | Continual | Pain Relief /Menstrual<br>pain relief | | | | | |
| Subject | Model | Max Freq<br>(Hz) | Max Pulse-Width<br>(us) | Max Voltage<br>(V) | Max avg.<br>current<br>(A) | Max charge<br>per pulse<br>(uC) | Electrode Area<br>(cm²) | Max. Average<br>Current<br>Density<br>(mA/cm²) | Maximum Average<br>Power<br>Density<br>(mW/cm²) |
| WL-2405H | | | | | | | | | |
| K172809 | CM-5050 | 210 | 245 | 40 | 0.08 | 19.6 | 25.0 | 0.16 | 0.007 |
| WL-2405H(M) | | | | | | | | | |
| Applying | CM-5050 | 210 | 245 | 40 | 0.08 | 19.6 | 25.0 | 0.16 | 0.007 |
| WL-2306E and WL-2306C | | | | | | | | | |
| K220524 | CM-7257 | 120 | 260 | 30 | 0.06 | 15.60 | 16.80 | 0.11 | 0.0033 |
| WL-2315E(M) and WL-2315C(M) | | | | | | | | | |
| Applying | CM-7257 | 100 | 100 | 30 | 0.06 | 6.00 | 16.80 | 0.04 | 0.0011 |

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# Comparison to Livia

Due to the fact that TENS/EMS electrical stimulator putput energy at lower impedance levels, and skin resistance only reaches 5002 under extreme or unusual conditions evaluations are conductions such as IEC 60601-2-10 and NS4. There standards assess the safety of electrical stimulator devices under the most hazardous conditions when output signals are delivered to the skin. In general, skin impedance is around 2000 to 27002.

For the subject device, although the voltage (current) at 5000 load shows slight differences compared to the suistance falls within the 2000 to 2700 range. After testing, we found the specifications are close to those of Livia (K183110), therefore it is considered substantially equivalent.

The following is a comparison of the values.

#### Livia K183110:

- At 500 ohms, the voltage is 50V
- At 2000 ohms, the voltage is 64V
- At 2700 ohms, the voltage is 64V

#### WL-2315C(M):

- · At 500 ohms, the voltage is 30V, with a difference of -66.7% compared to the Livia.
- · At 2000 ohms, the voltage is 61V, with a difference of -4.9% compared to the Livia.
- · At 2700 ohms, the voltage is 64V, with a difference of 0.0% compared to the Livia.

#### WL-2315E(M):

- · At 500 ohms, the voltage is 30V, with a difference of -66.7% compared to the Livia.
- · At 2000 ohms, the voltage is 61V, with a difference of -4.9% compared to the Livia.
- · At 2700 ohms, the voltage is 64V, with a difference of 0.0% compared to the Livia.

#### WL-2405H(M)-P9:

- · At 500 ohms, the voltage is 40V, with a difference of -25.0% compared to the Livia.
- · At 2000 ohms, the voltage is 64V, with a difference of 0.0% compared to the Livia.
- · At 2700 ohms, the voltage is 66V, with a difference of +3.0% compared to the Livia.

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Image /page/19/Picture/0 description: The image contains the logo for Well-Life Healthcare Limited. The logo features a yellow butterfly with the words "well-life" in blue on top of the butterfly. Below the words "well-life" are the words "SMARTER HEALTHCARE PRODUCTS, FOR BETTER LIVING" in a smaller font. Below the logo are the words "Well-Life Healthcare Limited" in a la…