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).

Device Description

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.

AI/ML Overview

The provided document is a 510(k) premarket notification from Well-Life Healthcare Limited to the FDA for their "Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator." This document asserts substantial equivalence to predicate devices and describes non-clinical testing performed. It explicitly states that no clinical performance testing was conducted or necessary for this device and indications for use. Therefore, no study proving the device meets acceptance criteria through clinical data is available in this document. The acceptance criteria for this device seem to be based solely on non-clinical performance (electrical safety, EMC, software validation) and comparisons to predicate devices for substantial equivalence.

Here's the information about the acceptance criteria and the provided device performance, based on the non-clinical testing and comparison to predicate devices, as no clinical study information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, the "acceptance criteria" are primarily established against benchmark engineering standards and comparison with predicate devices to demonstrate substantial equivalence, rather than specific performance metrics from a clinical study for a novel device. The document focuses on demonstrating that the subject device's technical specifications and safety profile are comparable to or within acceptable limits of the predicate devices and relevant electrical safety standards.

Acceptance Criteria (based on standards & predicate comparison)	Reported Device Performance (Subject Device)	Assessment (from document)
Electrical Safety & Performance (following standards)
Compliance with IEC 60601-1 (General basic safety)	Testing performed	Compliant (implied by "Testing was performed" and conclusion of substantial equivalence)
Compliance with IEC 60601-1-2 (EMC)	Testing performed	Compliant (implied by "Testing was performed" and conclusion of substantial equivalence)
Compliance with IEC 60601-1-11 (Home Healthcare)	Testing performed	Compliant (implied by "Testing was performed" and conclusion of substantial equivalence)
Compliance with IEC 60601-2-10 (Nerve & Muscle Stimulators)	Testing performed	Compliant (implied by "Testing was performed", assessment of voltage/current differences, and conclusion of substantial equivalence)
Compliance with AAMI NS4 (TENS)	Bench testing performed for output parameters	Compliant (implied by "Bench testing was performed" and conclusion of substantial equivalence)
Functional & Technical Equivalence to Predicates
Product Code (NUH, NGX, NYN)	NUH, NGX, NYN	Identical to primary predicate
Regulation Number (882.5890)	882.5890	Identical to both primary and secondary predicates
Power Source (3.7V Lithium-Ion Battery)	3.7V Lithium-Ion Battery	Identical to both primary and secondary predicates
Output Isolation (Electrical disabled when connected to charger)	Output is electrically disabled when connect to charger, by microprocessor charging circuit	Identical to both primary and secondary predicates
Max Output Voltage (e.g., 40V @500 ohm for WL-2405H(M))	WL-2405H(M): 40V @500 ohm; WL-2315E(M): 30V @500 ohm. Livia (secondary predicate): 50V @500 ohms, 64V @2000 ohms, 64V @2700 ohms. Subject devices (WL-2315C/E(M), WL-2405H(M)-P9) show differences at 500 ohms but are similar at higher impedances (2000-2700 ohms, where typical skin impedance falls).	Similar. Differences in voltage/current at 500 ohms are acknowledged but deemed not to compromise safety or effectiveness after evaluation against IEC 60601-2-10 and AAMI NS4 standards, particularly considering typical skin impedance (2000-2700 ohms) where values are closer to the predicate.
Max Output Current (e.g., 80mA @500 ohm for WL-2405H(M))	WL-2405H(M): 80mA @500 ohm; WL-2315E(M): 60mA @500 ohm. Livia (secondary predicate): 130.4mA @500 ohm.	Similar. Differences in voltage/current at 500 ohms are acknowledged but deemed not to compromise safety or effectiveness after evaluation against IEC 60601-2-10 and AAMI NS4 standards, particularly considering typical skin impedance (2000-2700 ohms) where values are closer to the predicate.
Pulse Width (e.g., TENS 2-245 us for WL-2405H(M))	WL-2405H(M): TENS 2-245 us, EMS 4-99 us. WL-2405H (primary predicate): TENS 2-245 us, EMS 4-99 us. Livia (secondary predicate): 100 us. WL-2315E/C(M): 100us vs. Reference 150-260 us.	Similar. "Electrical signal patterns utilized for relevant applications are consistent." Differences noted but considered not to compromise safety or effectiveness after evaluation vs. IEC 60601-2-10 and AAMI NS4.
Frequency (e.g., TENS 100-260 Hz for WL-2405H(M))	WL-2405H(M): TENS 100-260 Hz, EMS 200-300 Hz. WL-2405H (primary predicate): TENS 156-260 Hz, EMS 200-300 Hz. Livia (secondary predicate): 100 Hz. WL-2315E/C(M): 100Hz vs. Reference 15-120 Hz.	Similar. "Electrical signal patterns utilized for relevant applications are consistent." Differences noted but considered not to compromise safety or effectiveness after evaluation vs. IEC 60601-2-10 and AAMI NS4.
Indications for Use	Expands upon primary predicate (chronic pain, muscle soreness, EMS) by adding painful dysmenorrhea relief. Matches secondary predicate (Livia) for dysmenorrhea relief.	Substantially equivalent. The menstrual pain relief indication is supported by comparison to the Livia predicate. General pain and EMS indications are covered by the primary predicate.
Software Validation (per FDA guidance)	Required documentation provided in accordance with "General Principles of Software Validation: Final Guidance for Industry and FDA Staff" (11/05/2005).	Compliant.
Shelf Life & Sterilization	Shelf life for electrodes: 2 years (following FDA-2020-D-0957 and ASTM F1980-16).	Adequate.
Biocompatibility	No biocompatibility testing performed for subject device; electrodes used have already been cleared in K082065 and K200942.	Compliant (electrodes are pre-cleared).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not applicable. The document explicitly states: "No clinical performance testing was conducted or necessary for this device and indications for use." The testing described is non-clinical bench testing.
Data Provenance: The bench testing likely occurred at the manufacturer's facilities or a certified testing lab. The country of origin of the device manufacturer is Taiwan (Well-Life Healthcare Ltd., New Taipei City, Taiwan). The nature of this testing (electrical, EMC, software validation) means it's not "data provenance" in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. As no clinical performance testing was conducted, there were no "experts" establishing ground truth in a diagnostic or clinical efficacy sense. Ground truth, in the context of electrical safety and performance, is established by adherence to recognized international standards (e.g., IEC 60601 series, AAMI NS4) and internal design specifications.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as no clinical performance testing involving human adjudication was conducted. Assessment for non-clinical testing is typically pass/fail against predefined acceptance criteria for each test according to the relevant standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an electrical stimulator, not an AI-powered diagnostic or assistive tool for human readers (e.g., radiologists). No MRMC study was conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an electrical stimulator and does not involve an AI algorithm with standalone performance characteristics. Its function is to deliver electrical impulses.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical testing, the "ground truth" is defined by:
- International standards: e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, AAMI NS4.
- Manufacturer's design specifications: Bench testing verified output parameter specifications against these.
- FDA guidance documents: For software validation ("General Principles of Software Validation: Final Guidance for Industry and FDA Staff") and shelf life ("Shelf Life of Medical Devices").
- Predicate devices' established performance and safety profiles: For demonstrating substantial equivalence.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This device is not an AI/ML device that requires a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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:

For WL-2405H(M) model:

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	☐
Over-The-Counter Use (21 CFR 801 Subpart C)	☑

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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,23512, Taiwan
	Phone:	+886-2-22266981
	Fax:	+886-2-22266965
	Contact:	Jenny Hsieh(Jenny@welllifehealthcare.com.tw)
	Registration number:	3006850006

1. Identification of the device:

510(K) No	K233054
Subject Device Name:	Well-Life Pain relief (Menstrual Plus) ElectricalStimulator
Common or usual name:	Electrical stimulator, Transcutaneous electrical nervestimulator
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-23XXESeries)
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

Indications for use of the Subject Device:

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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)

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.

4. Description of the Device:

(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.
1. Biocompatibility
  No biocompatibility testing performed for this submission because to be used with the device have already been cleared in K082065 and K200942.
1. 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.
1. 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(Menstrual Plus) ElectricalStimulator	OTC Combo TENS/EMSSystem	Livia
Model	WL-2405H(M), WL-2315E(M),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. TENSGeneral Pain/ Menstrual painrelief/for WL-2405H(M)2. EMS	1. TENS(General Pain/)2. EMS	TENS(General Pain/ Menstrual painrelief)	Note. 1
Indications for Use	The Well-Life Pain Relief(Menstrual Plus) ElectricalStimulator includes threemodels: WL- 2315C(M),WL-2315E(M), andWL-2405H(M). Theindications for use are asfollows:For WL-2315C(M) and WL-2315E(M)	For temporary relief of pain associatedwith sore and aching muscles in thelower back due to strain from exerciseornormal household and work activities.(Choose TENS Modes P1 through P7)For temporary relief of pain associatedwith sore and aching muscles in theupper and lower extremities (armand/or leg) due to strain from exerciseor normal household and work	The Livia is designed forsymptomatic relief andmanagement of chronic pain,and for temporary relief ofpain associated with sore and achingmuscles in the shoulder, waist, back,neck, upper extremities (arm) andlower (extremities) leg due to strainfrom exercise or normal householdwork activities and for temporary reliefof pain associated with dysmenorrhea(menstrual cramps) when used withOTC 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-2315E(M) are designed for thesymptomatic relief andmanagement of pain. Theyoffer temporary relief frompain associated withdysmenorrhea (menstrualcramps) when used with over-the- counter pain medication.For WL-2405H(M)The WL-2405H(M) is designedfor symptomatic relief andmanagement of chronic painand provides temporary relieffrom sore and aching musclesin the shoulders, waist, back,neck, upper extremities (arms),and lower extremities (legs) dueto strain from exercise or dailyactivities. It also offerstemporary relief of painassociated with dysmenorrhea(menstrual cramps) when usedwith over-the-counter painmedication.Additionally, the WL-2405H(M) features EMSfunctionality for stimulatinghealthy muscles to enhance orfacilitate muscle performance(select EMS modes). It alsoprovides symptomatic relief and
management of chronic,intractable pain and relief frompain associated with arthritis(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 P1through P7)For symptomatic relief andmanagement of chronic, intractablepain and relief of pain associated witharthritis. (ChooseTENS Mode P8)For use by healthy adults for thestimulation of healthy muscles in orderto improve or facilitate muscleperformance.(Choose EMS Modes P1 through P6
Prescriptive or OTC	OTC	OTC	OTC	Identical
Number of output modes	WL-2315E(M), WL-2315C(M)1 mode for TENSWL-2405H(M)TENS: 10+EMS: 6	TENS: 8EMS: 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 CurrentIsolation	Output is electrically disabledwhen connect to charger, byOutput is electrically disabledwhen connect to charger, byIdentical 4-6 means ofmicroprocessor charging circuit	Output is electrically disabledwhen connect to charger, byOutput is electrically disabledwhen connect to charger, byIdentical 4-6 means ofmicroprocessor charging circuit	Output is electrically disabledwhen connect to charger, byOutput is electrically disabledwhen connect to charger, byIdentical 4-6 means ofmicroprocessor charging circuit	Identical
Patient Leakage Current- 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(μΑ)
Average DC currentthrough Electrodes whendevice is on but no pulsesare being applied (µA)	0 μΑ	0 μΑ	0 μΑ	Identical
Regulated Current orRegulated Voltage	Current	Current	Current	Identical
Software/Firmware/MicroprocessorControl	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:On/Off Status/LowBattery/Voltage/CurrentLevel	Yes	Yes	Yes	Identical
Number of outputchannels	WL-2405H(M): 2WL-2315E(M)/WL-2315C(M):1	2	1	Identical
Automatic no-load trip	Yes	Yes	Yes	Identical
Attribute	Subject Device	Primary Predicate Device:	Secondary Predicate Device:	Comparison
Patient override controlmethod	Yes	Yes	Yes	Identical
Maximum output voltage	WL-2405H(M): 40V @500 ohmWL-2315E(M): 30V @500 ohm	40V @500 ohm	65.6 V @500 ohm121V @2K ohm130.4V @10K ohm	SimilarNote. 3
Maximum output current	WL-2405H(M): 80mA@500 ohmWL-2315E(M):60mA@500 ohm	80mA@500 ohm	130.4 mA @500 ohm	SimilarNote. 3
Pulse width	TENS 2-245 usEMS 4-99 us	TENS 2-245 usEMS 4-99 us	100 us	SimilarNote. 3
Frequency	TENS 100-260 HzEMS 200-300 Hz	TENS 156-260 HzEMS 200-300 Hz	100 Hz	SimilarNote. 3
Accessories	Default accessoriesElectrode Pads (K082065)Optional accessoriesGarment electrodes (K200942)	Electrode Pads (K082065)	Electrode Pads	SimilarNote. 4
Compliance withvoluntary standard	60601-160601-1-260601-1-1160601-2-10	60601-160601-1-260601-1-1160601-2-10	60601-160601-1-260601-1-1160601-2-10	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(Primary Predicate Device)	WL-2405H(M)(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 2-245EMS 4-99	TENS 2-245EMS 4-99	Identical
Pulse Width range	TENS 156-260EMS 200-300	TENS 100-260EMS 200-300	SimilarNote.3
Preset Mode	TENS:8ModesEMS:6Modes	TENS: 10ModesEMS:6Modes	SimilarNote.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-2306EK220524(Reference Device 2)	/WL-2315E(M)(Applying)	/WL-2306CK220524(Reference Device 2)	/WL-2315C(M)(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(Vpp @ 500 ohm)	30V(Vpp @ 500 ohm)	30V(Vpp @ 500 ohm)	30V(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	3.7VLi-Rechargeable battery	3.7VLi-Rechargeable battery	3.7VLi-Rechargeable battery	3.7VLi-Rechargeable battery	Identical
Waveform	Asymmetrical squarepulse	Asymmetrical squarepulse	Asymmetrical squarepulse	Asymmetrical squarepulse	Identical
Frequency range (Hz)	15-120	100	15-120	100	SimilarNote.3
WidthPulserange(uSec)	150-260	100	150-260	100	SimilarNote.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 TimeUp-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 TimeUp-Hold-Down-OFF	Indications
Default (TENS P9)	100	100	Continual	Pain Relief /Menstrualpain relief
Subject	Model	Max Freq(Hz)	Max Pulse-Width(us)	Max Voltage(V)	Max avg.current(A)	Max chargeper pulse(uC)	Electrode Area(cm²)	Max. AverageCurrentDensity(mA/cm²)	Maximum AveragePowerDensity(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 larger font.

7.4 Comparison in Detail(s)

Note 1: The product's intended use is the same as the Primary Predicate Device, encompassing (1) TENS and (2) EMS functions. Additionally, it includes MENSTRUAL Relief. Therefore, we included the Secondary Predicate Device for comparison, which is cleared for both general pain relief using TENS and MENSTRUAL pain Relief.

Note 2: The differences between the product and the Primary Predicate Device are as follows: (1) WL-2405H(M) offers several additional programs, with the extra programs specifically designed for MENSTRUAL Relief. (2) These programs also apply to WL-2315E(M) and WL-2315C(M) as default output signals. The output signal specifications are similar to the Secondary Predicate Device.

Note 3: The product's effectiveness primarily depends on the pattern of electrical signals delivered to the skin (Pulse width, Frequency, DUTY TIME, etc.). After comparison, it has been verified that the electrical signal patterns utilized for relevant applications are consistent. While there are differences in voltage and current, these differences have been assessed through evaluations according to IEC 60601-2-10 and AAMI NS4 standards. It has been determined that these variances do not compromise safety or effectiveness and can be considered substantially equivalent to the predicate devices.

Note 4: A thorough evaluation based on IEC 60601-2-10 and AAMI NS4 standards has verified their compliance with electrical safety specifications when used with the cleared electrodes specified.

7.5 Conclusion:

In conclusion, the Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator has the same intended use as the primary and secondary predicate devices, and has similar technological characteristics and output specifications as these devices. The indications for use of the device are encompassed by the predicate devices, including TENS, arthritis, and dysmenorrhea pain. For these reasons, the subject device does not present any safety or effectiveness concerns and can be determined substantially equivalent to the predicate devices.

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
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.(b)
Classification. Class II (performance standards).