(162 days)
No
The device description focuses on basic electrical stimulation technology, battery changes, physical design differences, and manual button operation. There is no mention of AI, ML, data processing, or any features that would suggest intelligent or adaptive algorithms.
Yes
The device description explicitly states it provides "transcutaneous electrical nerve stimulation (TENS) for temporary relief of pain associated with sore and aching muscles," which indicates a therapeutic purpose.
No
This device is a TENS stimulator intended for pain relief, not for diagnosing medical conditions.
No
The device description clearly details hardware components such as a stimulator device with buttons, electrodes (patches and garments), and an external power adaptor for charging. It also mentions electrical signals and conductive materials, indicating a physical device that delivers electrical stimulation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary relief of pain associated with sore and aching muscles. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a TENS (Transcutaneous Electrical Nerve Stimulation) stimulator. TENS devices deliver electrical impulses to the skin to alleviate pain. This is a physical therapy modality, not a method for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a disease or condition based on sample analysis
- Using reagents or assays
The device's function is to provide electrical stimulation for pain relief, which falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
NUH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower extremities (arm and/or leg), low back, arthritis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
No clinical testing was conducted for this device.
Description of the test set, sample size, data source, and annotation protocol
No clinical testing was conducted for this device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical testing was conducted for this device.
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:
- 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).
- 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)]
- 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)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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 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)
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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:
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.
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.
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.
8. Statement of conformity
List of FDA-recognized voluntary consensus standards cited in this submission.
| Recognition
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 | Biological evaluation of medical devices - Part 10: Tests for
irritation and skin sensitization | 07/26/2016 |
| | | | |
| 19-4 | 2010-08-01
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 |
| 19-13 | 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)] | 12/23/2019 |
| 5-125 | ISO 14971
Third
Edition
2019-12 | Medical devices - Application
of risk management to medical devices | 12/23/2019 |
| 17-14 | ANSI/AAMI
I
NS4:2013(R)2
017 | Transcutaneous Electrical Nerve Stimulators
2013(R)2017 | 01/14/2019 |
| | FDA
guidance, | General Principle of Software Validation; Final Guidance for
Industry and FDA Staff" | January
11,
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:
-
- 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),
-
- 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)]
-
- 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 PATCH | |||
| Model: WL-2301A | Well-Life Mini TENS | |||
| Model: 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 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. | 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. | 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 | Synchronous | |||
| or | Synchronous | Synchronous | Same | |
| channels: | alternating? | |||
| Method of | ||||
| Channel Isolation | Output Coil | |||
| Voltage | Output Coil | |||
| Voltage | Same | |||
| Regulated Current or Regulated | ||||
| Voltage? | Same | |||
| Software/Firmware/Microprocessor | ||||
| control? | 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/Current | ||||
| Level? | Yes | Yes | Same | |
| Timer Range (Minutes) | 20 | 20 | Same | |
| Compliance | with Voluntary | |||
| Standards? | 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 |
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Image /page/10/Picture/0 description: The image shows the logo for Well-Life. The logo features a yellow butterfly with the words "well-life" in blue text on the right side of the butterfly. Below the company name is the text "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in smaller blue font.
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Image /page/11/Picture/0 description: The image shows the logo for Well-Life. The logo features a yellow butterfly with the words "well-life" 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 as | ||
| primary | ||||||
| WL-2306C/E:8 | See 2.3 | |||||
| Note.2 | ||||||
| Same as Ref. | ||||||
| Shape | Rectangular (With deformation on the top of each pulse) | Same as | ||||
| primary | ||||||
| Maximum Output Voltage(volts) | ||||||
| (+/- 20%) | 30V@500Ω | |||||
| 50V@2KΩ | ||||||
| 80V@10KΩ | WL-2301C/E | |||||
| 30V@500Ω | ||||||
| 50V@2KΩ | ||||||
| 80V@10KΩ | WL-2306C/E | |||||
| 30V@500Ω | ||||||
| 50V@2KΩ | ||||||
| 80V@10KΩ | 25V@500Ω | |||||
| 45V@2KΩ | ||||||
| 75V@10KΩ | Same as | |||||
| primary | ||||||
| Maximum Output Current(mA) | ||||||
| (+/-_20%) | 60mA@500Ω | |||||
| 25mA@2KΩ | ||||||
| 8mA@10KΩ | WL-2301C/E | |||||
| 60mA@500Ω | ||||||
| 25mA@2KΩ | ||||||
| 8mA@10KΩ | WL-2306C/E | |||||
| 60mA@500Ω | ||||||
| 25mA@2KΩ | ||||||
| 8mA@10KΩ | 50mA@500Ω | |||||
| 22.5mA@2KΩ | ||||||
| 7.5mA@10KΩ | Same as | |||||
| primary | ||||||
| Pulse Duration(usec) | WL-2301A: | |||||
| 250MAX | WL-2301C/E:250 | |||||
| WL-2306C/E:260 | WL-2406: | |||||
| 260MAX | Same as | |||||
| primary | ||||||
| See 2.3 |
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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: 60 | ||||
| MAX | WL-2301C/E:60 | WL-2406:120 | |||
| MAX | Same as | ||||
| primary | |||||
| See 2.3 | |||||
| Note.2 | |||||
| WL-2306C/E:120 | |||||
| For multiphasic | |||||
| waveforms only: | Symmetrical phases? | No | No | No | Same as |
| primary | |||||
| Phase Duration (include | |||||
| units), (Stage range, if | |||||
| applicable), (both phases | |||||
| if asymmetrical) | N/A | N/A | N/A | Same as | |
| primary | |||||
| Accessories or consumables | K082065/ | ||||
| CM7257 | |||||
| K082065/ | |||||
| CM169100 | K082065/ CM7257 | ||||
| K082065/CM169100 | |||||
| K082065/ CM13070 | |||||
| K200942/Garment Electrode EB | |||||
| K200942/Garment Electrode AM | |||||
| Exclusive accessories Back Belt | |||||
| Exclusive accessories Knee Belt | |||||
| Exclusive accessories Wrist Belt | K082065/ | ||||
| CM7257 | |||||
| K082065/ | |||||
| CM169100 | Note3 |
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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/ Original
Device (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/Garment
Electrode EB | Max Current Density (mA/cm²) | not applicable | 0.0733 |
| | Max Power Density (W/cm²) | not applicable | 0.0002 |
| K200942/Garment
Electrode AM | Max Current Density (mA/cm²) | not applicable | 0.0479 |
| | Max Power Density (W/cm²) | not applicable | 0.0001 |
| Exclusive accessories
Back Belt | Max Current Density (mA/cm²) | not applicable | 0.0748 |
| | Max Power Density (W/cm²) | not applicable | 0.0002 |
| Exclusive accessories
Knee Belt | Max Current Density (mA/cm²) | not applicable | 0.0479 |
| | Max Power Density (W/cm²) | not applicable | 0.0001 |
| Exclusive accessories
Wrist 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 Electric
Nerve Stimulators". The standard of "Maximum Average Current Density