For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household and work activities.

EMS can be used for the following applications:

For healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.

Heat Mode:

Heat can be used for temporary relief of minor aches and pains.

Device Description

Well-Life OTC TENS/EMS/Heating Stimulator Device, Model no. WL-2405K* provides a combination of 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, Electrical Muscle Stimulator (EMS) can be used to stimulate healthy muscles in order to facilitate muscle performance, relax muscle spasms, prevent or retard disuse atrophy, reeducate muscles and to maintain or increase the range of motion, Heat can be used in warming the muscle for soothing comfort.

The stimulator generates the output current specified as the input of controller. The output port transmits the output current & heat to the electrode, which is attached to the user's skin ; ; with the combination of the main 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, upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities, and to be used to stimulate healthy muscle in order to improve and facilitate muscle performance.

The device includes several operating elements, such as the ON/OFF button, intensity increase button, and intensity decrease button, and could be attached and detached to electrodes. The device has multiple program modes of different pulse frequencies, covering TENS/EMS and heat. While used in the heating mode, the device is coupled with electronically controlled electrodes to provide automatic thermal heat to the skin with the maximum temperature of 43°C.

For the heating cycle, the temperature will get to 43 degree Celsius in 130 seconds after turning on the heating mode, and when it reaches 43 degree Celsius then it will cool down to body temperature for 20 seconds, then back to 43 degree Celsius for 20 seconds , the cycle will continue for 15 minutes.

The device could be operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity, providing heat/temperature. Channel 1 can provide electrical stimulation signal, such as TENS/EMS, and it can only be performed by connecting an electrode and wire dedicated to electrical stimulation. Channel 2 can provide heat treatment, and it can only be carried out by connecting heat-exclusive electrode and wires. The exclusive accessories used for electrical stimulation or thermotherapy are marked by color to prevent misuse by the user. If you accidentally use it incorrectly, there will be a protective mechanism in the device to prevent it from operating and causing harm.

AI/ML Overview

Based on the provided text, the device in question is the "Well-Life TENS/EMS/Heating Stimulator (Model: WL-2405K+)". This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical acceptance criteria through a clinical study with detailed performance metrics.

Therefore, much of the information typically requested for demonstrating device performance against acceptance criteria in a clinical study (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is not applicable or not provided in this type of submission. This summary primarily relies on non-clinical testing (bench testing, usability, biocompatibility, electrical safety, shelf life, software validation) and direct comparison to predicate devices, asserting equivalence in safety and effectiveness.

Here's a breakdown of what can be extracted and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the standards the device claims to meet and the performance benchmarks of the predicate devices. However, explicit numerical acceptance criteria and direct performance results are primarily presented for non-clinical tests rather than clinical outcomes.

Criteria Category / Parameter	Acceptance Criteria (Implied/Standard)	Reported Device Performance (as stated in Non-Clinical Testing Summary or Comparison)
Usability	Compliance with IEC/EN 60601-1-6:2016 & IEC/EN 62366:2016	Meets the usability requirement as defined in the verification & validation test report.
Biocompatibility	Compliance with ISO 10993-1, -5, -10, -12 (Cytotoxicity, Sensitization, Irritation, Sample Prep)	Patient contacting components (electrode) are the same as a cleared predicate (K082065) and are in compliance with listed ISO 10993 standards.
Electromagnetic Compatibility & Electrical Safety	Compliance with IEC 60601-1, IEC 60601-1-11, ANSI/AAMI ES 60601-1, and Li-ion safety. Results meet IEC 60601-1 standard: Ed 3.	Results meet the requirement of IEC 60601-1 standard: Ed 3.
Performance (Electrical Stimulator)	Compliance with IEC 60601-2-10	Result meets the requirement of IEC 60601-2-10.
Shelf Life	Adequacy of shelf life per FDA-2020-D-0957 & ASTM F1980-16	Regarded as 2 years.
Software Validation	Compliance with "General Principles of Software Validation" (11/05/2005) guidance	Representative sample WL-2405K+ chosen for systematic assessment; required test reports provided.
Heating Temperature (Maximum)	Max 43°C (matching primary predicate)	43°C reached in 130 seconds, cycle continues for 15 minutes.
Heating Temperature (Low)	Specific value (e.g., 41°C of predicate)	Subject device: 42°C. Deemed substantially equivalent as difference from predicate's 41°C is minor.
Output Voltage (Vp, ±20%)	For 500Ω, 2KΩ, 10KΩ loads (compared to predicates)	Lower than primary predicate (e.g., 40V@500Ω vs 50V@500Ω), but deemed substantially equivalent. Same as secondary predicate.
Output Current (mAp, ±20%)	For 500Ω, 2KΩ, 10KΩ loads (compared to predicates)	Lower than primary predicate (e.g., 80mA@500Ω vs 100mA@500Ω), but deemed substantially equivalent. Same as secondary predicate.
Pulse Width (μs)	Compared to predicates	50 to 300 μs (Primary predicate: 50 to 450 μs; Secondary predicate: 50 to 300 μs). Deemed substantially equivalent based on safety and effectiveness.
Frequency (Hz)	Compared to predicates	1 to 100 Hz (Primary predicate: 1 to 150 Hz; Secondary predicate: 1 to 100 Hz). Deemed substantially equivalent based on safety and effectiveness.
Maximum Phase Charge (μC @ 500Ω)	Compared to predicates	TENS/EMS: 260(max) (Primary predicate: 45; Secondary predicate: 260(max)). Deemed substantially equivalent based on safety and effectiveness.
Maximum Current Density (mA/cm² @ 500Ω)	Compared to predicates	TENS Mode: 0.067; EMS Mode: 0.058 (Primary predicate: 0.667; Secondary predicate: TENS: 0.203, EMS: 0.095). Deemed substantially equivalent based on safety and effectiveness.
Maximum Power Density (W/cm² @ 500Ω)	Compared to predicates	TENS Mode: 0.0027; EMS Mode: 0.0023 (Primary predicate: 0.0046; Secondary predicate: TENS: 0.0081, EMS: 0.0038). Deemed substantially equivalent based on safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable. No clinical test set data is provided or mentioned as being used for substantial equivalence. The "test sets" mentioned refer to non-clinical bench testing.
Data Provenance: Not applicable for clinical data. For non-clinical tests, tests were conducted at an "accredited test laboratory" (location not specified beyond Taiwan for the manufacturer).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. No external "experts" were used to establish ground truth as no clinical test set requiring human interpretation for ground truth was performed or presented. The "ground truth" for the non-clinical tests is based on the specifications of the standards (e.g., IEC, ISO, ASTM).

4. Adjudication Method for the Test Set

Not applicable. No clinical test set involved human readers or ground truth requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "No clinical test data was used to support substantial equivalence." (Page 10, Section 9.1). Therefore, no MRMC study was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical stimulator, not an AI algorithm. Its performance is related to its electrical and heating outputs and physical characteristics.

7. The Type of Ground Truth Used

For Non-Clinical Tests: The "ground truth" is established by adherence to recognized voluntary consensus standards (e.g., IEC 60601-1, IEC 60601-2-10, ISO 10993 series, ASTM F1980-16, FDA guidances for software and shelf life). These standards define the acceptable range or performance for various parameters.
For Substantial Equivalence: The primary "ground truth" is the performance and indications of the legally marketed predicate devices. The claim is that the subject device is similar enough in terms of safety and effectiveness.

8. The Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, no training set for an algorithm.

Summary of the Study:

The "study" that proves the device meets the acceptance criteria is primarily a non-clinical evaluation documented in the "Non-Clinical Testing Summary" (Section 9) and a comparison to predicate devices for substantial equivalence (Section 10). The manufacturer performed:

Usability Testing: To meet IEC/EN 60601-1-6 and IEC/EN 62366 standards.
Biocompatibility Testing: Covering cytotoxicity, sensitization, and irritation, in compliance with ISO 10993 standards. It leverages the fact that the electrode is identical to one cleared in a predicate device.
Electromagnetic Compatibility and Electrical Safety Testing: To meet IEC 60601-1, IEC 60601-1-11, and ANSI/AAMI ES 60601-1 standards, and Li-ion battery safety.
Performance Testing: To meet the IEC 60601-2-10 standard for nerve and muscle stimulators.
Shelf Life Testing: Following FDA guidance and ASTM F1980-16.
Software Validation: Following FDA guidance on software for medical devices.

The entire submission is geared towards demonstrating substantial equivalence to existing predicate devices (HIVOX OTC Electrical Stimulator K203574 and Otc combo tens/ems system K172809) based on these non-clinical tests and a detailed comparison of technical specifications, rather than new clinical trials with patient outcomes. The premise of a 510(k) is that if a new device is as safe and effective as a legally marketed predicate device, it does not require a new PMA (Premarket Approval) process which typically involves extensive clinical data.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

February 19, 2022

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

Re: K213091

Trade/Device Name: Well-Life TENS/EMS/Heating Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX, IRT Dated: January 17, 2022 Received: January 21, 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Pamela Scott Assistant Director, Neuromodulation Psychiatry Devices 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) K213091

Device Name Well-Life TENS/EMS/Heating Stimulator

Indications for Use (Describe) The WL-2405K+ is a digital electrical and heat stimulator for active treatment application as the following:

TENS can be used for the following applications:

For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household and work activities.

EMS can be used for the following applications:

For healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.

Heat Mode:

Heat can be used for temporary relief of minor aches and pains.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/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".

Section 5 510(k) Summary

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510(K) Summary

1. Type of Submission: Traditional
1. Preparation date: 17th September, 2021 Revision date: 19th February, 2022
1. 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 device:

Device Name:	Well-Life TENS/EMS/HeatingStimulator
Common or usual name:	Electrical Heating Stimulator
Device Model:	WL-2405K+
Classification product code:	NUH
Subsequent product code:	NGX, IRT
Device Classification:	II
Regulation Number:	1) 882.58902) 890.58503) 890.5740
Regulation description:	1) Transcutaneous electrical nervestimulator for pain relief2) Powered muscle stimulator3) Power heating pad
Review panel:	1) Neurology2) Physical Medicine3) Physical Medicine

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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" in blue on the right wing. Below the company name is the text "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in a smaller font, also in blue.

Identification of the Predicate Device:

Primary Predicate Device (K203574)

Device Name:	HIVOX OTC Electrical Stimulator
Common or usual name:	Electrical Heating Stimulator
Device Model:	EM-59-2
Classification product code:	NUH
Subsequent product code:	NGX, IRT
Device Classification:	II
Regulation Number:	1) 882.58902) 890.58503) 890.5740
Regulation description:	1) Transcutaneous electrical nervestimulator for pain relief2) Powered muscle stimulator3) Power heating pad
Review panel:	1) Neurology2) Physical Medicine3) Physical Medicine

Secondary Predicate Device (K172809)

Device Name:	Otc combo tens/ems system
Common or usual name:	OTC Combo TENS/EMS System
Device Model:	WL-2405G, WL-2405H
Classification product code:	NUH
Subsequent product code:	NGX NYN
Device Classification:	II
Regulation Number:	1) 882.58902) 890.5850
Regulation description:	1) Transcutaneous electrical nervestimulator for pain relief2) Powered muscle stimulator
Review panel:	1) Neurology2) Physical Medicine

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Image /page/6/Picture/0 description: The image shows a logo for "well-life", which is written in a stylized font. Below the name is the tagline "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in smaller, sans-serif font. The logo is set against a yellow butterfly shape, which serves as a backdrop and design element.

Intended Use and Indications for use of the Subject Device:

The WL-2405K* is a digital electrical and heat stimulator for active treatment application as the following.
TENS can be used for the following applications:
. For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household and work activities.
EMS can be used for the following applications:
. For healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.
Heat Mode:
. Heat can be used for temporary relief of minor aches and pains.

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Image /page/7/Picture/0 description: The image shows a logo for "well-life" with the tagline "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING". The logo features a yellow butterfly shape with the word "well-life" written across it in a stylized font. The tagline is written in smaller letters below the brand name. The overall design is simple and clean, with a focus on the brand name and tagline.

7. Description of the Device:

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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 "well-life" written in blue on the butterfly's wing. 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 a sense of health and well-being.

8. Statement of conformity

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

RecognitionNumber	Standard DesignationNumber and Date	Title Of Standard	Date OfRecognition
5-89	IEC 60601-1-6Edition 3.1 2013-10	Medical electrical equipment - Part 1-6:General requirements for basic safety andessential performance - Collateral standard:Usability	06/27/2016
5-114	IEC 62366-1Edition 1.0 2015-02	Medical devices - Part 1: Application ofusability engineering to medical devices	12/23/2016
2-258	ISO 10993-1 Fifth Edition2018-08	Biological evaluation of medical devices -Part 1: Evaluation and testing within a riskmanagement process	01/14/2019
2-245	ISO 10993-5 Third Edition2009-06-01	Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity	02/23/2016
2-174	ISO 10993-10 ThirdEdition 2010-08-01	Biological evaluation of medical devices -Part 10: Tests for irritation and skinsensitization	07/26/2016
2-191	ISO 10993-12 FourthEdition 2012-07-01	Biological evaluation of medical devices -Part 12: Sample preparation and referencematerials	07/26/2016
19-4	IEC 60601-1:2005, MOD	Medical electrical equipment- Part 1:General requirements for basic safety andessential performance	07/09/2014
19-8	IEC 60601-1-2:2014	Medical electrical equipment -- Part 1-2:General requirements for basic safety andessential performance -- CollateralStandard: Electromagnetic disturbances --Requirements and tests	09/17/2018
19-14	IEC 60601-1-11 Edition2.0 2015-01	Medical electrical equipment- Part 1-11:General requirements for basic safety andessential performance – Collateral Standard:Requirements for medical electricalequipment and medical electrical systemsused in the home healthcare environment	06/27/2016
17-16	IEC 60601-2-10 Edition2.1 2016-04	Medical electrical equipment - Part 2-10:Particular requirements for the basic safetyand essential performance of nerve andmuscle stimulators	06/27/2016
17-14	ANSI AAMINS4:2013(R)2017	Transcutaneous Electrical NerveStimulators 2013(R)2017	01/14/2019
FDAGuidance	FDA-2020-D-0957	Shelf Life of Medical Devices	April 1991
14-497	ASTM F1980-16	Standard Guide for Accelerated Aging ofSterile Barrier Systems for Medical Devices	12/23/2016
FDAGuidance	Guidance for industry andFDA Staff	Guidance for the Content of PremarketSubmissions for Software Contained inMedical Device	11/05/2005

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Image /page/9/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 "well-life" written in blue letters over the butterfly. Below the company name is the tagline "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in smaller, blue letters.

9. Non-Clinical Testing Summary:

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) Usability Test

The applicable standard for the performance of Well-Life TENS/EMS/Heating Stimulator (model: WL-2405K*) device is given on IEC/EN 60601-1-6:2016 & IEC/EN 62366:2016. Based on the verification & validation testing model WL-2405K+ is considered to meet the usability requirement as defined in the verification & validation test report.

1. Biocompatibility
  The patient contacting materials of the Well-Life TENS/EMS/Heating Stimulator (model: WL-2405K+) are the "electrode, cutaneous FDA Cleared (K082065)". The electrode is exactly the same as cleared with the Predicate Device OTC Combo TENS/EMS System (model: WL-2405G/H, K172809).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), irritation (ISO 10993-10 Third Edition 2010-08-01) and Sample preparation and reference materials (ISO 10993-12 Fourth Edition 2012-07-01)
1. Electromagnetic Compatibility and Electrical Safety The applicable standard for the electric safety of Well-Life TENS/EMS/Heating Stimulator (model: WL-2405K*) is given on IEC 60601-1 or ANSI/AAMI ES

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Image /page/10/Picture/0 description: The image shows a logo for "well-life" which is written in a stylized font. The text below the company name reads "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in a smaller font. The logo is set against a yellow butterfly shape, with the company name and slogan placed within the butterfly's wings.

60601-1. The representative Well-Life TENS/EMS/Heating Stimulator (model: WL-2405K*) is tested by accredited test laboratory. The following electric safety tests are performed. They are 1. ANSI/AAMI ES 60601-1 test, 2. IEC 60601-1-11 test and 3. Li-ion safety test. After evaluation, the results meet the requirement of IEC 60601-1 standard: Ed 3.

1. Performance Testing Bench testing was performed to verify the performance to specifications of the proposed device and included the following: The applicable standard for the performance of Well-Life TENS/EMS/Heating Stimulator (model: WL-2405K*) device is given on IEC 60601-2-10. The representative Well-Life TENS/EMS/Heating Stimulator (model: WL-2405K*) is tested by accredited test laboratory. After test, the result meets the requirement of IEC 60601-2-10.
1. Shelf Life Test

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, basically the shelf life for The Well-Life TENS/EMS/Heating Stimulator (model: WL-2405K+) is regard as 2 years.

1. Software Validation.
  Generally, the applicable standard for the Software Validation Report of TENS/EMS/Heating stimulator device is given on "General Principles of Software Validation"; Final Guidance for Industry and FDA Staff Document issued on: 11/05/2005". In order to prove that the Software Validation for the submission model complies with the requirement of" General Principles of Software Validation", the representative sample WL-2405K+ is chosen for the systematic assessment of this standard. Based on the systematic assessment, some required test reports are provided. For the testing report of Software Validation.

9.1. Clinical Testing Summary

No clinical test data was used to support substantial equivalence.

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10. Substantial Equivalence Determination:

10.1 Substantial Equivalence Comparison to Predicate Device

Elements of Comparison	Subject Device	Primary Predicate	Secondary Predicate	Remark
Company	Well-Life Healthcare Limited	HIVOX BIOTEK INC.	Well-Life Healthcare Limited	--
Device Name	Device name:Well-Life TENS/EMS/HeatingStimulatorModel: WL-2405K+	Device name:HIVOX OTC ElectricalStimulatorModel: EM59-1, EM59-2	Device name:OTC Combo TENS/EMS SystemModel:WL-2405G, WL-2405H	--
Product Code	NUH NGX IRT	NUH NGX IRT	NUH NGX NYN	Same
Regulation Number	882.5890	882.5890	882.5890	Same
Product K Number	Applying	K203574	K172809	--
OTC/Rx	OTC	OTC	OTC
Indication for use	The WL-2405K+ is a digitalelectrical and heat stimulator foractive treatment application as thefollowing.TENS can be used for thefollowing applications:• For temporary relief of painassociated with sore and achingmuscles in the shoulder, waist,back, upper extremities (arm) andlower extremities (leg) due tostrain from exercise or normalhousehold and work activities.	TENS: This function isdesignated to be used fortemporary relief of painassociated with sore and achingmuscles in the shoulder, waist,back, upper extremities (arm) andlower extremities (leg) due tostrain from exercise or normalhousehold work activities.	TENS: It can be used for thetemporary relief of painassociated with sore and achingmuscles in the shoulder, waist,back, upper extremities (arm) andlower extremities (leg), due tostrain from exercise or normalhousehold	Note 1
	EMS can be used for the followingapplications:• For healthy adults for thestimulation of healthy muscles inorder to improve or facilitatemuscle performance.Heat Mode:• Heat can be used for temporaryrelief of minor aches and pains.	EMS: This function is designed tobe used for stimulating healthymuscles in order to improve andfacilitate muscle performance.SH: This function is designed tobe used for temporary relief ofminor aches and pains.	EMS: It can be used for thestimulation of healthy muscles inorder to improve or facilitatemuscle performance.SH: NA
Power Source(s)	Rechargeable battery	Rechargeable battery	Rechargeable battery	Same
Function and Design	Electrical stimulation and heat	Electrical stimulation and heat	Electrical stimulation	Note 1
Heating Setting	Low and High	Low and High	NA	Note 1
Maximum Temperature Setting	43°C	43°C	NA	Note 1
Maximum	$40V @500Ω$	$50V @500Ω$	$40V @500Ω$	Note.2
Output Voltage (Vp, ±20%)	$60V @2KΩ$	$90V @2KΩ$	$60V @2KΩ$
	$88V @10KΩ$	$125V @10KΩ$	$88V @10KΩ$
Maximum	$80mA @500Ω$	$100mA @500Ω$	$80mA @500Ω$	Note.2
Output Current (mAp, ±20%)	$30mA @2KΩ$	$45mA @2KΩ$	$30mA @2KΩ$
	$8.8mA @10KΩ$	$12.5mA @10KΩ$	$8.8mA @10KΩ$
Pulse width (μs)	50 to 300	50 to 450	50 to 300	Note.2
Frequency (Hz)	1 to 100	1 to 150	1 to 100	Note.3
Maximum Phase Charge	TENS Mode: 260(max)	45	TENS Mode: 260(max)	Note.3
( $\mu$ C @ 500 $\Omega$ )	EMS Mode:260(max)		EMS Mode:260(max)
Maximum Current Density(mA/cm² @ 500 $\Omega$ )	TENS Mode: 0.067EMS Mode:0.058	0.667	TENS Mode: 0.203EMS Mode:0.095	Note.3
Maximum Power Density(W/cm² @ 500 $\Omega$ )	TENS Mode: 0.0027EMS Mode:0.0023	0.0046	TENS Mode:0.0081EMS Mode:0.0038	Note.3
Output Signal	Electrical stimulation onlyHeat only	Electrical stimulation onlyHeat onlyElectrical stimulation + Heatsimultaneously	Electrical stimulation only	Note 1
Method of Line Current Isolation	N/A(Internal power source)	N/A(Internal power source)	N/A(Internal power source)	SAME
Number of output Channels	2 Synchronous	2 Synchronous	2 Synchronous	SAME
Method of Channel Isolation	By electrical circuit and software	By electrical circuit and software	By electrical circuit and software	SAME
Software/Firmware/MicroprocessorControl?	Yes	Yes	Yes	SAME
Automatic Overload Trip?Automatic No-Load Trip?Automatic Shut Off?	Yes	Yes	Yes	SAME
Patient Override Control?	Yes	Yes	Yes	SAME
Indicator DisplayON/OFF Status?Low battery?	Yes	Yes	Yes	SAME
Intensity Level?
Compliant with VoluntaryStandards?	IEC60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-10	IEC60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-10	IEC60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-10	SAME
Compliant with 21 CFR 898?	Yes	Yes	Yes	SAME
Housing Materials andConstruction	Plastic (ABS) enclosure	Plastic (ABS) enclosure	Plastic (ABS) enclosure	SAME
Waveform	Biphasic	Biphasic	Biphasic	SAME
Shape	Rectangular	Rectangular	Rectangular	SAME
Output Intensity	TENS: Level 0 to 25EMS: Level 0 to 25SH: Level LOW and HI	TENS: Level 0 to 50EMS: Level 0 to 50SH: Level LOW and HI	TENS: Level 0 to 25EMS: Level 0 to 25	Note.4
Heating Level (°C)	LOW: up to 42Level HI: up to 43	LOW: up to 41Level HI: up to 43	N/A	Note.5

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Image /page/14/Picture/0 description: The image shows a logo for a company called "well-life". The logo features a yellow butterfly with the company name written in blue text. Below the company name, there is a tagline that reads "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING".

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10.2 Comparison in Detail(s):

● Note 1

1. Indication for use, Function and Design, Heating Setting and Maximum Temperature Setting of the subject device are identical to the primary predicate device except the Output Signal.
1. The option for the Output Signal of primary predicate device is Electrical stimulation only, Heat only and Electrical stimulation + Heat simultaneously. The option for the Output Signal of subject device is Electrical stimulation only, Heat only. Since the option for the Output Signal of subject device is not more than primary predicate device and identical to the others, therefore can be considered as substantial equivalent.
1. Regard to the secondary predicated device, it is selected to be considered as substantial equivalent.in some electrical design of the subject device. Refer to Note 2, 3 and 4.
1. In TENS mode, the designed program in both subject device and primary predicate devices, from P1~P7 have the same output character. The secondary predicate device has an additional P8 mode for pain associated with arthritis. However, the subject device has not been found substantially equivalent to demonstrate safety and effectiveness for pain associated with arthritis and thus requires clinical evidence for this indication.

● Note 2

The Output Voltage and Current of the subject device is slightly lower than primary predicate device, but the intensity of heating is identical as 43℃, therefore can be considered as substantial equivalent

● Note 3

Since the Pulse width, Frequency, Maximum Phase Charge, Maximum Current Density, Maximum Power Density are the different design and specification in the different brand of electrical stimulator. Therefor the safety and effectiveness are the key points. The technical data of the output specifications of Pulse width (us), Frequency (Hz), Maximum Phase Charge (uC (@ 500Ω), Maximum Current Density (mA/cm² @ 500Ω), Maximum Power Density (W/cm² @ 500Ω) for the subject

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device are shown as Section 18.3 NS4 Report. The result in comparing the subject device can be considered as substantial equivalent

● Note 4

The Intensity of the subject device is slightly lower than secondary predicate device, but the function and performance is similar, therefore can be considered as substantial equivalent

● Note 5

1. The High Heating Level (℃) of the subject device are identical to the primary predicate device.
1. The Low Heating Level (℃) of the primary predicate device is 41℃ and the subject device is 42°C. Since the Low Heating Level (°C) of subject device is not higher than primary predicate device and identical to the High Heating Level (℃) and the difference between 42℃ and 41℃ is minor , therefore can be considered as substantial equivalent.
1. Regard to the secondary predicated device, it is selected to be considered as substantial equivalent.in some electrical design of the subject device. Refer to Note 2, 3 and 4.

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11. Conclusion:

Those 5 Notes indicated the differences among Subject devices, Primary and Secondary Predicate devices. Each note is explained respectively, especially in the safety, functions and performance which are applying in the Subject device are substantially equivalent with Primary Predicate devices. The Secondary predicated device is provided for being the reference in the technical design. After Evaluation, the subject device has all feature of predicate devices. The few differences are explained and no matter with impact of the safety and effectiveness. Thus, the subject device is substantially equivalent with 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).