Intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

Device Description

Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series) provides a transcutaneous electrical nerve stimulation (TENS) for temporary relief of pain associated with sore and aching muscles due to strain from exercise, normal household chores and work-related activities. The output port transmits the output signal to the electrode, which is attached to the user's skin; with the combination of the Stimulator device parts, the device can be placed on the treatment locations as recommended in the user manual for temporary relief of pain associated with sore and aching muscles in the low back, arthritis as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

The Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series) is design changed from OTC MINI PATCH K121353 (Model WL-2301A/WL-2301B).

The main differences between the two are disposable battery change to reusable battery, aside from battery changes, the appearance of the devices is also differnt. Also, minor changes include PCBA component placement changes, frame size changes, and new accessories to improve convenience.

The definition of model name: WL is abbreviation of Well-Life Healthcare Limited. 23 is symbol of device series which are wireless, no monitor and operated by buttoning only. XX is the symbol for different program and output electrical signal in this device. The last English alphabet is the symbol of the appearance of this device, For C, it is oval shape and for E, it is round shape. The model of Stimulator device are WL-2301C, WL-2301E, WL-2306C and WL-2306E, which include operating elements, such as the ON/OFF button, intensity increase button, and intensity decrease button, and could be attached and detached to electrodes. The Stimulator device offers several different preset programs, and will switch automatically, with 21 minutes per session and will turn off automatically after each session. The Stimulator device could be operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity.

The accessories of Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series) are electrode which can be patch or garment. 3 models of patches and 5 models of garments are recommended. There are CM7257, CM169100, CM13070 for electrode patch and Well-Life Garment Electrode -Arm (GM-AM-O-X00), Well-Life Garment Electrode -Elbow (GM-EB-O-X00). Well-Life Garment Electrode -Back Strech Belt (EW-BK-00IE), Well-Life Garment Electrode - Wrist (EW-WR-00IE) and Well-Life Garment-Knee (EW-KN-002E).

The electrode Pad composed of non-woven fabric, conductive layer and conductive gel, it is connected to the stimulator through buttons or wires, and is in contact with the skin through conductive gel to transmit electrical signal to the skin to achieve therapeutic effects.

The Well-Life Garment Electrode series are blending by Non-conductive textile and conductive textile, from the name of the conductive garment the user can identify the applicable body part, and the textile technology is adjusted to make the product fit on the skin. It is connected to the stimulator through buttons or wires, and is in contact with the skin through conductive textile to transmit electrical signal to the skin to achieve therapeutic effects.

The Stimulator device can connect to a specified external IEC 60601-1 compliant power supply for charging of the internal lithium-ion battery. The accessories must comply with AAMI/ ANSI/ES60601- 1, IEC 60601-1-2 and IEC 60601-2-10. The accessories include: An external power adaptor, an electrode cord I cable attached to electrodes pads and battery.

AI/ML Overview

This document is a 510(k) summary for the Well-Life Mini TENS Stimulator, which is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief. The purpose of this summary is to demonstrate substantial equivalence to a legally marketed predicate device, not to present a de novo clinical study with specific acceptance criteria in the typical sense for an AI/ML device.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (such as sensitivity, specificity, or AUC) is not applicable to this submission. This 510(k) summary is for a medical device that relies on established TENS technology and demonstrates substantial equivalence through non-clinical bench testing, biocompatibility testing, and comparisons to predicate devices based on technical specifications and safety standards.

The document explicitly states: "No clinical testing was conducted for this device." This means there was no study performed to measure the device's performance against clinical endpoints or to assess how it might improve human reader performance with AI assistance. As such, there are no acceptance criteria, sample sizes, expert ground truth establishment, or adjudication methods as would be found in a study for an AI/ML algorithm requiring such validation.

Instead, the "acceptance criteria" for this device's clearance were its adherence to relevant electrical safety, biocompatibility, and performance standards for TENS devices, and its demonstrated substantial equivalence (based on design, intended use, energy type, etc.) to already cleared predicate devices.

Here's a breakdown of the information that is available in the document, framed against your request, highlighting why some points are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a TENS device relying on substantial equivalence to predicates, the "acceptance criteria" are compliance with relevant safety and performance standards for TENS devices and demonstrating that its specifications are similar to or justify differences from the predicate. The "reported device performance" are the results of non-clinical bench testing and adherence to these standards.

Acceptance Criteria (based on standards & predicate comparison)	Reported Device Performance / Compliance
Biocompatibility (ISO 10993-1, -5, -10)	In compliance, no concerns
Electrical Safety (IEC 60601-1, -1-2, -1-11, -2-10)	Met all design specifications
Battery Safety (IEC 62133)	Met all design specifications
Performance Bench Testing (IEC 60601-2-10, ANSI AAMI NS4)	Met all design specifications
Usability Engineering (IEC 60601-1-6, IEC 62366-1)	Met all design specifications
Risk Management (ISO 14971)	Applied
Device Specifications vs. Primary Predicate (K121353)	(See tables on pages 9-13)
Regulation Number (882.5890)	Same
Product Code (NUH)	Same
OTC/Rx	Same (OTC)
Indication for use	Same
Method of Line current Isolation (Type BF)	Same
Patient Leakage Current (Normal <0.1μA, Single Fault <0.5μA)	Same (Under 0.1, Under 0.5)
Average DC current through electrodes (when device on but no pulses)	Same (Not applicable)
Number of Output channels (Synchronous)	Same
Method of Channel Isolation (Output Coil Voltage)	Same
Software/Firmware/Microprocessor control	Same (Yes)
Automatic Overload/No-Load Trip	Same (No, Yes)
Automatic Shut Off	Same (Yes)
User Override control	Same (No)
Indicator (On/Off, Low Battery, Voltage/Current Level)	Same (Yes for all)
Timer Range (Minutes)	Same (20)
Compliance with Voluntary Standards	Same (ES60601-1, IEC60601-1-2, IEC60601-2-10, IEC 60601-1-11)
Compliance with 21 CFR 898	Same (Yes)
Output Signal Specification vs. Primary Predicate (K121353)	(See tables on pages 11-13)
Waveform	Bia-phasic (consistent with TENS)
Number of Output Modes (WL-2301C/E)	Same as primary predicate (3)
Number of Output Modes (WL-2306C/E)	Different from primary, same as secondary predicate (8)
Shape (Rectangular)	Consistent
Max Output Voltage (WL-2301C/E, WL-2306C/E)	Same as primary predicate
Max Output Current (WL-2301C/E, WL-2306C/E)	Same as primary predicate
Pulse Duration (WL-2301C/E)	Same as primary predicate (250MAX)
Pulse Duration (WL-2306C/E)	Consistent with secondary predicate (260MAX)
Frequency (WL-2301C/E)	Same as primary predicate (60MAX)
Frequency (WL-2306C/E)	Consistent with secondary predicate (120MAX)
Symmetrical phases	Same (No)
Max output charge per pulse (uC)	15 (WL-2301C/E), 15.6 (WL-2306C/E)
Max average current (mA)	0.9 (WL-2301C/E), 1.87 (WL-2306C/E)
Max output power (W)	0.027 (WL-2301C/E), 0.056 (WL-2306C/E)
Max Current Density (< 2 mA/cm²)	All reported values below threshold
Max Power Density (< 0.25 W/cm²)	All reported values below threshold

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable. No clinical testing with human subjects was conducted. Non-clinical bench testing was performed on device units.
Data Provenance: Not applicable in the context of clinical data. The data stems from internal laboratory testing of the device and comparison of its specifications to predicate devices. The country of origin for the submitter is Taiwan.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There was no "test set" requiring ground truth established by medical experts in the context of diagnostic or prognostic performance. The device is a therapeutic TENS stimulator.

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

Not applicable. No test set requiring expert adjudication was used.

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 not an AI/ML diagnostic or assistive tool, and no MRMC study was performed.

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

Not applicable. This is not an AI algorithm.

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

Not applicable. In the context of performance testing for substantial equivalence, the "ground truth" is compliance with established engineering and safety standards (e.g., IEC 60601 series, ISO 10993 series, ANSI AAMI NS4) and demonstrating that the device's technical specifications fall within acceptable ranges as compared to its predicate devices.

8. The sample size for the training set:

Not applicable. There is no AI/ML algorithm in this device that requires a training set.

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

Not applicable. No training set was used.

Summary

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

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 and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 4, 2022

Well-Life Healthcare Limited Jenny Hsieh 6F., No.168, Lide St., Jhonghe District New Taipei City, 23512 Taiwan

Re: K220524

Trade/Device Name: Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: April 28, 2022 Received: May 6, 2022

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 (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 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

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

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K220524

Device Name

Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series) Model:WL-2301C/ WL-2301E/ WL-2306C/ WL-2306E

Indications for Use (Describe)

Intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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

Image /page/3/Picture/0 description: The image shows the logo for Well-Life, a company that sells healthcare products. The logo features a yellow butterfly with the words "well-life" in green letters on top of the butterfly. Below the company name is the text "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in smaller, blue letters. The logo is simple and eye-catching, and it conveys the company's focus on health and well-being.

510(K) Summary

1. Type of Submission:	Traditional
2. Preparation date:	28th April, 2022
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

4. Identification of the subject device:

510K No. (Applying) Trade/Device Name: Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series) Model: WL-2301C/WL-2301E/WL-2306C/WL-2306E Regulation Number: 21 CFR 882.5890 Transcutaneous Electrical Nerve Stimulator for Pain Regulation Name: Relief Regulatory Class: Class II Product Code: NUH

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

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 butterfly shape in yellow, with the text integrated into the design. The word "well-life" is written in a stylized font, with the tagline appearing in smaller letters beneath it.

Identification of the Predicate

Primary Predicate:

The OTC MINI PATCH K121353 (Model WL-2301A/WL-2301B) by Well-Life Healthcare Ltd. which has been cleared by Food and Drug Administration. The Subject Device is designed based on this product, so the specifications and parameters of electrical stimulation are substantial equivalent. The following is the basic information of the product.

510K No.	K121353
Trade/Device Name:	OTC MINI PATCH K121353
Model:	WL-2301A/WL-2301B
Regulation Number:	21 CFR 882.5890
Regulation Name:	Transcutaneous Electrical Nerve Stimulator for Pain Relief
Regulatory Class:	Class II
Product Code:	NUH

Secondary Predicate Device

The OTC PATCH K133723 (Model WL-2406) by Well-Life Healthcare Ltd. which has been cleared by Food and Drug Administration.

The Output Mode (Out Put Signal) of subject device WL-2306C and WL-2306E were reference from The OTC PATCH K133723 (Model WL-2406) so the output mode of electrical stimulation is substantial equivalent. The following is the basic information of the product.

510K No. K133723

Trade/Device Name: OTC PATCH

Model: WL-2406

Regulation Number: 21 CFR 882.5890

Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain

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

Image /page/5/Picture/0 description: The image shows a logo for a company called "well-life". The logo features a yellow butterfly with the company name in blue text. Below the company name is the tagline "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in smaller, also blue, text. The overall design is simple and clean, with a focus on the butterfly as a symbol of transformation and well-being.

Well-I ife Healthcare I imited

Well-Life Healthcare Limited

Relief
Regulatory Class:	Class II
Product Code:	NUH

6. Intended Use and Indications for use of the Subject Device:

Intended for temporary relief of pain Same associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

7. Description of the Device:

The Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series) is design changed from OTC MINI PATCH K121353 (Model WL-2301A/WL-2301B).

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

Image /page/6/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 words "well-life" in blue text above the butterfly. Below the butterfly, the words "Smarter Healthcare Products for Better Living" are written in smaller, red text. The logo is simple and clean, and the colors are bright and cheerful.

8. Statement of conformity

List of FDA-recognized voluntary consensus standards cited in this submission.

RecognitionNumber	StandardDesignationNumber andDate	Title Of Standard	Date OfRecognition
5-89	IEC 60601-1-6Edition 3.12013-10	Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essential performance -Collateral standard: Usability	06/27/2016
5-114	IEC 62366-1Edition 1.02015-02	Medical devices - Part 1: Application of usabilityengineering to medical devices	12/23/2016
2-258	ISO 10993-1Fifth Edition2018-08	Biological evaluation of medical devices - Part 1: Evaluationand testing within a risk management process	01/14/2019
2-245	ISO 10993-5Third Edition2009-06-01	Biological evaluation of medical devices - Part 5: Tests forin vitro cytotoxicity	02/23/2016
2-174	ISO 10993-10Third Edition	Biological evaluation of medical devices - Part 10: Tests forirritation and skin sensitization	07/26/2016

19-4	2010-08-01IEC 60601-1:2005, MOD	Medical electrical equipment- Part 1: General requirementsfor basic safety and essential performance	07/09/2014
19-8	IEC 60601-1-2:2014	Medical electrical equipment -- Part 1-2: Generalrequirements for basic safety and essential performance --Collateral Standard: Electromagnetic disturbances --Requirements and tests	09/17/2018
19-14	IEC 60601-1-11Edition 2.02015-01	Medical electrical equipment- Part 1-11: Generalrequirements for basic safety and essential performance –Collateral Standard: Requirements for medical electricalequipment and medical electrical systems used in the homehealthcare environment	06/27/2016
17-16	IEC 60601-2-10Edition 2.12016-04	Medical electrical equipment - Part 2-10: Particularrequirements for the basic safety and essential performanceof nerve and muscle stimulators	06/27/2016
19-13	IEC 62133Edition2.0 2012-12	Secondary cells and batteriescontaining alkaline or other non-acid electrolytes - Safetyrequirements for portable sealed secondary cells, and forbatteries made from them, for use in portable applications[Including: Corrigendum 1(2013)]	12/23/2019
5-125	ISO 14971ThirdEdition2019-12	Medical devices - Applicationof risk management to medical devices	12/23/2019
17-14	ANSI/AAMIINS4:2013(R)2017	Transcutaneous Electrical Nerve Stimulators2013(R)2017	01/14/2019
	FDAguidance,	General Principle of Software Validation; Final Guidance forIndustry and FDA Staff"	January11,2002.

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

Image /page/7/Picture/0 description: The image shows the logo for Well-Life. The logo features a yellow butterfly with the words "well-life" in a sans-serif font superimposed on the butterfly's wings. Below the company name is the tagline "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in a smaller font.

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

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 words "well-life" written in blue on top of the butterfly. Below the company name is the tagline "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in smaller, blue font. The logo is simple and eye-catching, and it conveys the company's focus on health and well-being.

9. Clinical Testing Summary:

No clinical testing was conducted for this device.

10. Non-Clinical Testing Summary:

The following non-clinical testing was conducted in the subject devices. Those tests showed that the device met all design specifications, demonstrated safety based on current industry standards:

1. Biocompatibility Patient contacting components are in compliance with ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, including cytotoxicity (ISO 10993-5 Third Edition 2009-06-01), sensitization (ISO 10993-10 Third Edition 2010-08-01),
1. EMC and Electrical Safety was performed to verify the electrical specifications of the proposed device and included the following:
· IEC 60601-1:2005, MOD Medical electrical equipment- Part 1: General requirements for basic safety and essential performance
· IEC 60601-1-2:2014, Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
· IEC 60601-1-11 Edition 2.0 2015-01, Medical electrical equipment- Part 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
· IEC 62133 Edition 2.0 2012-12, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications [Including: Corrigendum 1 (2013)]
1. Performance Testing Bench testing was performed to verify the performance to specifications of the proposed device and included the following:
Particular requirements for the basic safety and essential performance of nerve and muscle stimulators (IEC 60601-2-10 Edition 2.1 2016-04)
Transcutaneous Electrical Nerve Stimulators 2013(R)2017 (ANSI AAMI NS4:2013(R)2017)
• Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601- 1-6 Edition 3.1 2013-10) and Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1 Edition 1.0 2015-02)

{9}------------------------------------------------

Image /page/9/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. Below the company name is the slogan "Smarter Healthcare Products for Better Living" in smaller, black text.

10. Substantial Equivalence Determination:

10.1 Substantial Equivalence Comparison to Predicate/ Original Device (Regular Specification)

		Primary Predicate Device	Subject Device
Device Name		OTC MINI PATCHModel: WL-2301A	Well-Life Mini TENSModel: WL-23XXC/WL-23XXE Series	--
510(K) Number		K121353	Applying	--
Regulation Number		882.5890	882.5890	Same
Product Code		NUH	NUH	Same
OTC/Rx		OTC	OTC	Same
Indication for use		Intended for temporary relief of pain Sameassociated with sore and aching muscles in theupper and lower extremities (arm and/or leg) dueto strain from exercise or normal household andwork activities.	Intended for temporary relief of pain Sameassociated with sore and aching muscles in theupper and lower extremities (arm and/or leg) dueto strain from exercise or normal household andwork activities.	Same
Power Source(s)		3V (CR2032)	Rechargeable Li-Battery	Note1
-Method of Line current Isolation		Type BF	Type BF	Same
-Patient Leakage Current		---	---	--
-Normal condition(μA)		Under 0.1	Under 0.1	Same
-single Fault condition(μA)		Under 0.5	Under 0.5	Same
Average DC current through electrodes		Not applicable	Not applicable	Same
when device is on but no pulses are
being applied(μA)
Number of Output	Synchronousor	Synchronous	Synchronous	Same
channels:	alternating?
	Method ofChannel Isolation	Output CoilVoltage	Output CoilVoltage	Same
Regulated Current or RegulatedVoltage?				Same
Software/Firmware/Microprocessorcontrol?		Yes	Yes	Same
Automatic Overload Trip?		No	No	Same
Automatic No-Load Trip?		Yes	Yes	Same
Automatic Shut Off?		Yes	Yes	Same
User Override control?		No	No	Same
Indicator	On/Off Status?	Yes	Yes	Same
Display:	Low Battery?	Yes	Yes	Same
	Voltage/CurrentLevel?	Yes	Yes	Same
Timer Range (Minutes)		20	20	Same
Compliance	with VoluntaryStandards?	ES60601-1, IEC60601-1-2, IEC60601-2-10,IEC 60601-1-11	ES60601-1, IEC60601-1-2, IEC60601-2-10,IEC 60601-1-11	Same
Compliance with 21 CFR 898?		Yes	Yes	Same
Weight(g) including battery		14.2g	23.8g	--
Dimensions (mm.) [L x W x H]		593013.0 mm (LWH)	WL-2301C/2306C: 644116.7 mm (LWH)WL-2301/2306E: 564915.9 mm (LWH)	--
Housing Materials and construction		ABS	ABS	Same

{10}------------------------------------------------

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 on the right side of the butterfly. Below the company name is the text "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in smaller blue font.

{11}------------------------------------------------

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" written across the top wing. Below the name is the tagline "Smarter Healthcare Products for Better Living" in smaller text.

10.2 Substantial Equivalence Comparison to Predicate/ Original Device (Output Signal Specification)

	Primary		Subject Device	Second Predicate
	K121353			K133723
Model Number	WL-2301A		WL-2301C/E, WL-2306C/E	WL-2406
Waveform (e.g., pulsed monophasic, biphasic)			Bia-phasic
Number of Output Modes	WL-2301A: 3		WL-2301C/E:3	WL-2406:8	Same asprimary
			WL-2306C/E:8		See 2.3Note.2Same as Ref.
Shape		Rectangular (With deformation on the top of each pulse)			Same asprimary
Maximum Output Voltage(volts)(+/- 20%)	30V@500Ω50V@2KΩ80V@10KΩ		WL-2301C/E30V@500Ω50V@2KΩ80V@10KΩ	WL-2306C/E30V@500Ω50V@2KΩ80V@10KΩ	25V@500Ω45V@2KΩ75V@10KΩ	Same asprimary
Maximum Output Current(mA)(+/-_20%)	60mA@500Ω25mA@2KΩ8mA@10KΩ		WL-2301C/E60mA@500Ω25mA@2KΩ8mA@10KΩ	WL-2306C/E60mA@500Ω25mA@2KΩ8mA@10KΩ	50mA@500Ω22.5mA@2KΩ7.5mA@10KΩ	Same asprimary
Pulse Duration(usec)	WL-2301A:250MAX		WL-2301C/E:250WL-2306C/E:260	WL-2406:260MAX	Same asprimarySee 2.3

{12}------------------------------------------------

Image /page/12/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 top of the butterfly. Below the words "well-life" are the words "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in a smaller font.

					Note.2
Frequency (Hz) [or Rate (pps)]		WL-2301A: 60MAX	WL-2301C/E:60	WL-2406:120MAX	Same asprimarySee 2.3Note.2
			WL-2306C/E:120
For multiphasicwaveforms only:	Symmetrical phases?	No	No	No	Same asprimary
	Phase Duration (includeunits), (Stage range, ifapplicable), (both phasesif asymmetrical)	N/A	N/A	N/A	Same asprimary
Accessories or consumables		K082065/CM7257K082065/CM169100	K082065/ CM7257K082065/CM169100K082065/ CM13070K200942/Garment Electrode EBK200942/Garment Electrode AMExclusive accessories Back BeltExclusive accessories Knee BeltExclusive accessories Wrist Belt	K082065/CM7257K082065/CM169100	Note3

{13}------------------------------------------------

Image /page/13/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 across the center. Below the company name is the text "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in smaller blue font.

	Predicate/ OriginalDevice (WL-2301A)	Subject device(WL-2301C / WL-2301E)	Subject device(WL-2306C / WL-2306E)
Maximum output charge per pulse (uC)		15	15.6
Maximum average current (mA)		0.9	1.87
Maximum output power (W)		0.027	0.056
K082065/ CM7257	Max Current Density (mA/cm²)	0.0549	0.1140
K082065/ CM169100	Max Power Density (W/cm²)	0.0016	0.0003
	Max Current Density (mA/cm²)	0.0281	0.0584
K082065/ CM13070	Max Power Density (W/cm²)	0.0008	0.0002
	Max Current Density (mA/cm²)	not applicable	0.0584
	Max Power Density (W/cm²)	not applicable	0.0002
K200942/GarmentElectrode EB	Max Current Density (mA/cm²)	not applicable	0.0733
	Max Power Density (W/cm²)	not applicable	0.0002
K200942/GarmentElectrode AM	Max Current Density (mA/cm²)	not applicable	0.0479
	Max Power Density (W/cm²)	not applicable	0.0001
Exclusive accessoriesBack Belt	Max Current Density (mA/cm²)	not applicable	0.0748
	Max Power Density (W/cm²)	not applicable	0.0002
Exclusive accessoriesKnee Belt	Max Current Density (mA/cm²)	not applicable	0.0479
	Max Power Density (W/cm²)	not applicable	0.0001
Exclusive accessoriesWrist Belt	Max Current Density (mA/cm²)	not applicable	0.1247
	Max Power Density (W/cm²)	not applicable	0.0004
The device and accessories are developed base on "IEC60601-2-10" and "ANSI AAMI NS4:2013(R)2017 Transcutaneous ElectricNerve Stimulators". The standard of "Maximum Average Current Density < 2 mA/cm²" refers to "IEC60601-2-10 Clause 201.4.and the standard of "Maximum Peak Power Density < 0.25W/cm²" refer to "ANSI AAMI NS4:2013(R)2017 Transcutaneous

{14}------------------------------------------------

Image /page/14/Picture/0 description: The image features the logo for Well-Life Healthcare Limited. The logo includes a stylized yellow butterfly graphic with the words "well-life" in blue, stacked on top of the phrase "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in a smaller font. Below the logo, the company name "Well-Life Healthcare Limited" is written in a larger, clear font.

3. Comparison in Detail(s):

Note 1

The Power Source of Subject Device is changed into Rechargeable. By the study data from the section 14, 15, 17, 18, 21 and 22, it can be identified to be substantial equivalent to the Predicated Device.

Note 2

The Output Signal Specification of Model no. WL-2301C/E of Subject device is identical to Predicated device.

The Output Signal Specification of Model no. WL-2306C/E of Subject device is minor different from Predicated device but same as Reference Device (K133723, WL-2406).

Thus, based on the above conclusions, we believe that the slight modification of the Subject device is not impact safety and effectiveness.

For comparison of related safety specifications, Annex of NS4 table is stated. The difference of Output Signal Specification is minor and can be adjusted. Therefore, the Output Signal Specification of Model no. WL-2306C/E of Subject device can be identified to be substantial equivalent to the Predicated Device.

Note 3

With regard to Accessories or consumables, 2 items are recommended to use with the predicated device and 8 items are with the subject device. The additional 6 contain 3 FDA approval (K082065/ CM13070, K200942/Garment Electrode EB, K200942/Garment Electrode AM and 3 Non-FDA approval (Exclusive accessories Back Belt, Exclusive accessories Knee Belt and Exclusive accessories Wrist Belt. Those 3 Non-FDA approval garment electrodes are extensive model of K200942/Garment Electrode and necessary tests are conducted and no concern in the safety and effectiveness.

4. Conclusion:

After Comparison and Evaluation, the subject device Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE Series) has all same feature as predicate devices. No matter with impact of the safety or effectiveness is considered and studied.

{15}------------------------------------------------

Image /page/15/Picture/0 description: The image shows a logo for "well-life". The logo features a stylized yellow butterfly with the text "well-life" superimposed on its upper wing. Below the company name, there is a tagline that reads "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in smaller, sans-serif font. The overall design is clean and suggests a focus on health and well-being.

The minor differences are explained and no matter with impact of the safety and effectiveness. Thus, the subject device is substantially equivalent with the Predicate Device: OTC MINI PATCH Model: WL-2301A (K121353).

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).