(148 days)
Not Found
No
The device description focuses on basic electrical stimulation and heating functions controlled by manual buttons and pre-set programs. There is no mention of adaptive algorithms, learning from data, or any features typically associated with AI/ML. The performance studies are standard bench testing and safety evaluations, not AI/ML model validation.
Yes
The device is described as a "digital electrical and heat stimulator for active treatment application" with intended uses like "temporary relief of pain associated with sore and aching muscles" and "stimulation of healthy muscles in order to improve or facilitate muscle performance," which align with the definition of a therapeutic device. It also explicitly mentions providing "heat treatment" for "soothing comfort" and "temporary relief of minor aches and pains."
No.
The device is described as a stimulator for active treatment applications (TENS, EMS, Heat Mode) for pain relief and muscle stimulation, not for diagnosing conditions. Its intended uses are therapeutic, not diagnostic.
No
The device description clearly outlines hardware components such as electrodes, wires, buttons, and a main device body that generates electrical current and heat. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a digital electrical and heat stimulator for active treatment applications like pain relief (TENS), muscle stimulation (EMS), and temporary relief of aches and pains (Heat). These are all therapeutic applications, not diagnostic ones.
- Device Description: The description details how the device generates electrical current and heat and transmits it to electrodes placed on the skin for therapeutic purposes. It does not mention any analysis of biological samples (blood, urine, tissue, etc.) which is a core characteristic of IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to apply physical stimuli (electrical and heat) to the body for therapeutic effects.
N/A
Intended Use / Indications for Use
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.
Product codes
NUH, NGX, IRT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, upper extremities (arm) and lower extremities (leg)
Indicated Patient Age Range
healthy adults
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- 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.
- Biocompatibility: The patient contacting materials are in compliance with ISO 10993-1, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), irritation (ISO 10993-10) and Sample preparation and reference materials (ISO 10993-12).
- Electromagnetic Compatibility and Electrical Safety: The applicable standard is IEC 60601-1 or ANSI/AAMI ES 60601-1. The representative Well-Life TENS/EMS/Heating Stimulator (model: WL-2405K*) is tested by accredited test laboratory. Electrical safety tests performed include ANSI/AAMI ES 60601-1 test, IEC 60601-1-11 test and Li-ion safety test. Results meet the requirement of IEC 60601-1 standard: Ed 3.
- Performance Testing: Bench testing was performed. 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.
- Shelf Life Test: 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. The shelf life is regarded as 2 years.
- Software Validation: The applicable standard is "General Principles of Software Validation"; Final Guidance for Industry and FDA Staff Document issued on: 11/05/2005". Based on systematic assessment, required test reports are provided.
No clinical test data was used to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
2
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)
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."
3
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
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 yellow butterfly shape, with the text "well-life" in a dark blue font positioned on the upper right wing of the butterfly. Below the company name, the tagline is written in a smaller, lighter blue font.
510(K) Summary
-
- Type of Submission: Traditional
-
- Preparation date: 17th September, 2021 Revision date: 19th February, 2022
-
- 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/Heating
Stimulator |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| 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) 882.5890
2) 890.5850
3) 890.5740 |
| Regulation description: | 1) Transcutaneous electrical nerve
stimulator for pain relief
2) Powered muscle stimulator
3) Power heating pad |
| Review panel: | 1) Neurology
2) Physical Medicine
3) Physical Medicine |
5
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) 882.5890 |
- 890.5850
- 890.5740 |
| Regulation description: | 1) Transcutaneous electrical nerve
stimulator for pain relief - Powered muscle stimulator
- Power heating pad |
| Review panel: | 1) Neurology - Physical Medicine
- 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) 882.5890 |
- 890.5850 |
| Regulation description: | 1) Transcutaneous electrical nerve
stimulator for pain relief - Powered muscle stimulator |
| Review panel: | 1) Neurology - Physical Medicine |
6
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.
7
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:
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.
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 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.
| Recogniti
on
Number | Standard Designation
Number and Date | Title Of Standard | Date Of
Recognition |
|---------------------------|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| 5-89 | IEC 60601-1-6
Edition 3.1 2013-10 | Medical electrical equipment - Part 1-6:
General requirements for basic safety and
essential performance - Collateral standard:
Usability | 06/27/2016 |
| 5-114 | IEC 62366-1
Edition 1.0 2015-02 | Medical devices - Part 1: Application of
usability engineering to medical devices | 12/23/2016 |
| 2-258 | ISO 10993-1 Fifth Edition
2018-08 | Biological evaluation of medical devices -
Part 1: Evaluation and testing within a risk
management process | 01/14/2019 |
| 2-245 | ISO 10993-5 Third Edition
2009-06-01 | Biological evaluation of medical devices -
Part 5: Tests for in vitro cytotoxicity | 02/23/2016 |
| 2-174 | ISO 10993-10 Third
Edition 2010-08-01 | Biological evaluation of medical devices -
Part 10: Tests for irritation and skin
sensitization | 07/26/2016 |
| 2-191 | ISO 10993-12 Fourth
Edition 2012-07-01 | Biological evaluation of medical devices -
Part 12: Sample preparation and reference
materials | 07/26/2016 |
| 19-4 | IEC 60601-1:2005, MOD | Medical electrical equipment- Part 1:
General requirements for basic safety and
essential performance | 07/09/2014 |
| 19-8 | 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 | 09/17/2018 |
| 19-14 | 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 | 06/27/2016 |
| 17-16 | IEC 60601-2-10 Edition
2.1 2016-04 | Medical electrical equipment - Part 2-10:
Particular requirements for the basic safety
and essential performance of nerve and
muscle stimulators | 06/27/2016 |
| 17-14 | ANSI AAMI
NS4:2013(R)2017 | Transcutaneous Electrical Nerve
Stimulators 2013(R)2017 | 01/14/2019 |
| FDA
Guidance | FDA-2020-D-0957 | Shelf Life of Medical Devices | April 1991 |
| 14-497 | ASTM F1980-16 | Standard Guide for Accelerated Aging of
Sterile Barrier Systems for Medical Devices | 12/23/2016 |
| FDA
Guidance | Guidance for industry and
FDA Staff | Guidance for the Content of Premarket
Submissions for Software Contained in
Medical Device | 11/05/2005 |
9
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.
-
- 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)
- Biocompatibility
-
- 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
10
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.
-
- 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.
-
- 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.
-
- 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.
- Software Validation.
9.1. Clinical Testing Summary
No clinical test data was used to support substantial equivalence.
11
Image /page/11/Picture/0 description: The image shows the logo for Well-Life. The logo features the text "well-life" in a blue, sans-serif font. Below the text is the tagline "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in a smaller font. To the left of the text is a yellow butterfly.
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/Heating | ||||
| Stimulator | ||||
| Model: WL-2405K+ | Device name: | |||
| HIVOX OTC Electrical | ||||
| Stimulator | ||||
| Model: EM59-1, EM59-2 | Device name: | |||
| OTC Combo TENS/EMS System | ||||
| Model: | ||||
| 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 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. | TENS: This function is
designated to be used 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 work activities. | TENS: It can be used for the
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 | Note 1 |
| | 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. | EMS: This function is designed to
be used for stimulating healthy
muscles in order to improve and
facilitate muscle performance.
SH: This function is designed to
be used for temporary relief of
minor aches and pains. | EMS: It can be used for the
stimulation of healthy muscles in
order to improve or facilitate
muscle 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: 0.067
EMS Mode:0.058 | 0.667 | TENS Mode: 0.203
EMS Mode:0.095 | Note.3 |
| Maximum Power Density
(W/cm² @ 500 $\Omega$ ) | TENS Mode: 0.0027
EMS Mode:0.0023 | 0.0046 | TENS Mode:0.0081
EMS Mode:0.0038 | Note.3 |
| Output Signal | Electrical stimulation only
Heat only | Electrical stimulation only
Heat only
Electrical stimulation + Heat
simultaneously | 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/Microprocessor
Control? | 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 Display
ON/OFF Status?
Low battery? | Yes | Yes | Yes | SAME |
| Intensity Level? | | | | |
| Compliant with Voluntary
Standards? | IEC60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-10 | IEC60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-10 | IEC60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-10 | SAME |
| Compliant with 21 CFR 898? | Yes | Yes | Yes | SAME |
| Housing Materials and
Construction | 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 25
EMS: Level 0 to 25
SH: Level LOW and HI | TENS: Level 0 to 50
EMS: Level 0 to 50
SH: Level LOW and HI | TENS: Level 0 to 25
EMS: Level 0 to 25 | Note.4 |
| Heating Level (°C) | LOW: up to 42
Level HI: up to 43 | LOW: up to 41
Level HI: up to 43 | N/A | Note.5 |
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 text across the top right wing. Below the company name is the phrase "Smarter Healthcare Products for Better Living" in smaller blue text.
13
Image /page/13/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".
14
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".
15
Image /page/15/Picture/0 description: The image shows a logo for "well-life". The logo features a yellow butterfly shape with the words "well-life" in blue on top of the butterfly. Below the butterfly, there is some text that says "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING".
10.2 Comparison in Detail(s):
● Note 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.
-
- 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.
-
- 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.
-
- 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
16
Image /page/16/Picture/0 description: The image shows the logo for "well-life", which is written in blue text. The logo also includes the tagline "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in smaller, yellow text. To the left of the text is a yellow butterfly.
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
-
- The High Heating Level (℃) of the subject device are identical to the primary predicate device.
-
- 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.
-
- 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.
17
Image /page/17/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 above the butterfly. Below the company name is the tagline "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in smaller blue text. The logo is simple and clean, with a focus on the company name and tagline.
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.