(389 days)
No
The document describes a standard electrical stimulator with preset modes and user-adjustable parameters. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for the symptomatic relief and management of various types of pain, including chronic pain, pain associated with dysmenorrhea, sore and aching muscles, and arthritis pain. It also has EMS functionality to enhance or facilitate muscle performance, which are all therapeutic interventions.
No
The device is designed for symptomatic relief and management of pain, not for diagnosing conditions.
No
The device description explicitly states it is an "Electrical Stimulator" and details hardware components like an LCD/LED display, output channels, and modes for TENS and EMS, which are electrical stimulation modalities requiring hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for symptomatic relief and management of pain, including menstrual cramps and muscle pain. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is described as an "Electrical Stimulator" that uses TENS and EMS technology. These are methods of applying electrical currents to the body for therapeutic purposes, not for analyzing samples from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening.
The device is clearly intended for direct application to the body to alleviate pain and stimulate muscles, which falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For WL-2315C(M) and WL-2315E(M) models:
The WL-2315C(M) and WL-2315E(M) are designed for the symptomatic relief and management of pain. They offer temporary relief from pain associated with dysmenorrhea (menstrual cramps) when used with over-the- counter pain medication.
For WL-2405H(M) model:
The WL-2405H(M) is designed for symptomatic relief and management of chronic pain and provides temporary relief from sore and aching muscles in the shoulders, waist, back, upper extremities (arms), and lower extremities (legs) due to strain from exercise or daily activities. It also offers temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication.
Additionally, the WL-2405H(M) features EMS functionality for stimulating healthy muscles to enhance or facilitate muscle performance (select EMS modes). It also provides symptomatic relief and management of chronic, intractable pain and relief from pain associated with arthritis (select TENS mode P8).
Product codes (comma separated list FDA assigned to the subject device)
NUH, NGX, NYN
Device Description
The Well-Life Pain relief (Menstrual Plus) Electrical Stimulator is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower (extremities) leg due to strain from exercise or normal household work activities. It also provides symptomatic relief and management of chronic, intractable pain and relief from pain associated with arthritis This stimulator should be applied to the normal, healthy, dry, and clean skin of adult patients with the aim of stimulating healthy muscles and enhancing muscle performance.
There are three available models: WL-2405H(M), WL-2315E(M), and WL-2315C(M). WL-2405H(M) is derived from the WL-2405H (FDA 510K no. K172809) with modifications. It includes the original TENS modes P1-P8 and EMS modes P1-P6, along with two additional TENS modes (P9, P10). TENS P9 is used for Pain Relief/Menstrual pain relief, while TENS P10 is suitable for Pain Relief. The WL-2405H(M) model offers 16 preset modes, with 10 modes for TENS (Transcutaneous Electrical Nerve Stimulation) and 6 modes for EMS (Electrical Muscle Stimulation). It features an LCD/LED display and a user-friendly interface that allows for adjustments to preset modes, output signal intensity, and treatment duration. It also includes two output channels.
The WL-2315E(M)/WL-2315C(M) model is a distinct version that exclusively focuses on the TENS P9 mode for dysmenorrhea pain relief, derived from the WL-2405H(M) model. This series of products is an adaptation of the mini-TENS stimulator (wl-23xxc/wl-23xxe series) family (FDA 510K no. K220524), with identical external design and internal components, software, etc., with the only modification being the Output Signal. This model has three buttons for power on/off and intensity adjustment and is intended for use with the specified preset mode, providing relief for chronic pain and sore muscles in various body areas. It is for alleviating pain associated with dysmenorrhea (menstrual cramps).
The Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator must be used with 510K cleared Electrode pads (K082065) and Garment electrodes (K200942). These accessories are available for purchase along with the device or separately as supplementary packs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulders, waist, back, neck, upper extremities (arms), and lower extremities (legs)
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
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:
- Sterilization and Shelf Life: To demonstrate the adequacy of the shelf life, the recommended study process for the similar product released on guidance document FDA-2020-D-0957 "Shelf Life of Medical Devices" and ASTM F1980-16 "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices "is followed. After test and study, the shelf life for electrodes to be used with the device is 2 years.
- Biocompatibility: No biocompatibility testing performed for this submission because to be used with the device have already been cleared in K082065 and K200942.
- Software Validation: The FDA guidance document titled "General Principles of Software Validation: Final Guidance for Industry and FDA Staff"issued on 11/05/2005" was used to validate software used in the device. Required documentation was provided in accordance with this guidance document.
- Electromagnetic compatibility and electrical safety: Testing was performed to verify the electromagnetic compatibility and electrical safety of the subject device using the following standards: IEC60601-1, IEC-60601-1-2, IEC-60601-1-11, IEC-60601-2-10.
- Bench testing was performed to verify the output parameter specifications of the device using the AAMI NS4(2013) standard for Transcutaneous Electrical Nerve Stimulators.
No clinical performance testing was conducted or necessary for this device and indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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 & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 18, 2024
Well-Life Healthcare Limited Jenny Hsieh Official Correspondent 6F., No. 168, Lide St., Jhonghe District New Taipei City, Taiwan 235
Re: K233054
Trade/Device Name: Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator: TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator Regulation Number: 21 CFR 882.5890, 21 CFR 890.5850 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX, NYN Dated: September 2, 2024 Received: September 18, 2024
Dear Jenny Hsieh:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Robert Kang -S
for Pamela Scott
Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233054
Device Name
Well-Life Pain Relief (Menstrual Stimulator: TENS/EMS WITH Menstrual Relief Stimulator: Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator
Indications for Use (Describe)
For WL-2315C(M) and WL-2315E(M) models:
The WL-2315C(M) and WL-2315E(M) are designed for the symptomatic relief and management of pain. They offer temporary relief from pain associated with dysmenorrhea (menstrual cramps) when used with over-the- counter pain medication.
For WL-2405H(M) model:
The WL-2405H(M) is designed for symptomatic relief and management of chronic pain and provides temporary relief from sore and aching muscles in the shoulders, waist, back, upper extremities (arms), and lower extremities (legs) due to strain from exercise or daily activities. It also offers temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication.
Additionally, the WL-2405H(M) features EMS functionality for stimulating healthy muscles to enhance or facilitate muscle performance (select EMS modes). It also provides symptomatic relief and management of chronic, intractable pain and relief from pain associated with arthritis (select TENS mode P8).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ☐ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ |
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Image /page/4/Picture/0 description: The image shows a logo for "well-life" with the tagline "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING." The logo features a stylized yellow butterfly shape, with the word "well-life" superimposed on the butterfly's wing. The tagline is written in smaller letters below the company name.
Well-Life Healthcare Limited 510(K) Statement
| 1. | Type of Submission: | Traditional |
|---|---|---|
| 2. | Preparation date: | 10/17/2024 |
| 3. | Submitter: | Well-Life Healthcare Ltd. |
| Address: | 6F. No.168, Lide St., Jhonghe District, New Taipei City, | |
| 23512, Taiwan | ||
| Phone: | +886-2-22266981 | |
| Fax: | +886-2-22266965 | |
| Contact: | Jenny Hsieh | |
| (Jenny@welllifehealthcare.com.tw) | ||
| Registration number: | 3006850006 |
1. Identification of the device:
| 510(K) No | K233054 |
|---|---|
| Subject Device Name: | Well-Life Pain relief (Menstrual Plus) Electrical |
| Stimulator | |
| Common or usual name: | Electrical stimulator, Transcutaneous electrical nerve |
| stimulator | |
| Model: | WL-2405H (M), WL-2315C (M), WL-2315E (M) |
| Classification name: | stimulator, nerve, transcutaneous, over-the-counter |
| Classification Panel: | Neurology |
| Device Classification: | II |
| OTC/RX | OTC |
| Regulation Number: | 21 CFR Part 882.5890 |
| Primary Product Code | NUH |
| Secondary product codes | NGX, NYN |
2. Identification of the Predicate Devices:
| Primary Predicate Device: | |
|---|---|
| 510(K) No | K172809 |
| Device Name: | OTC Combo TENS/EMS System |
| Model: | WL-2405H, WL-2405(G) |
| Classification name: | stimulator, nerve, transcutaneous, over-the-counter |
| Classification Panel: | Neurology |
| Device Classification: | II |
| OTC/RX | OTC |
| Regulation Number: | 21 CFR Part 882.5890 |
| Product Code | NUH, NGX, NYN |
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Image /page/5/Picture/0 description: The image shows the logo for Well-Life. The logo features a yellow butterfly with the words "well-life" written in blue on the butterfly's wing. Below the company name is the text "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING".
| Secondary Predicate Device: | |
|---|---|
| 510(K) No | K183110 |
| Device Name: | Livia |
| Model: | -- |
| Classification name: | stimulator, nerve, transcutaneous, over-the-counter |
| Classification Panel: | Neurology |
| Device Classification: | II |
| OTC/RX | OTC |
| Regulation Number: | 21 CFR Part 882.5890 |
| Product Code | NUH |
| Reference Device 1: Accessories | ||
|---|---|---|
| 510(K) No | K082065 | |
| Device Name: | WELL LIFE SELF ADHESIVE ELECTRODE | |
| Model: | CM, FA, PU AND SP | |
| Classification name: | Electrode, Cutaneous | |
| Classification Panel: | Neurology | |
| Device Classification: | II | |
| OTC/RX | OTC+RX | |
| Regulation Number: | 21 CFR Part 882.1320 | |
| Product Code | GXY |
| Reference Device 2: Reference | |
|---|---|
| 510(K) No | K220524 |
| Device Name | Well-Life Mini TENS Stimulator (WL-23XXC/WL-23XXE |
| Series) | |
| Model: | WL-2301E/WL-2301C |
| Classification name: | Stimulator, Nerve, Transcutaneous, Over-the-Counter |
| Classification Panel: | Neurology |
| Device Classification: | II |
| OTC/RX | OTC |
| Regulation Number: | 882.5890 |
| Product Code | NUH |
- Indications for use of the Subject Device:
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Image /page/6/Picture/0 description: The image shows a logo for "well-life". The logo features a yellow butterfly with the text "well-life" in blue on the right side of the butterfly. Below the text is the phrase "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in smaller, dark text.
Indications for use
Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator The Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator includes three models: WL-2315C(M), WL-2315E(M), and WL-2405H(M). The indications for use are as follows:
For WL-2315C(M) and WL-2315E(M)
The WL-2315C(M) and WL-2315E(M) are designed for the symptomatic relief and management of pain. They offer temporary relief from pain associated with dysmenorrhea (menstrual cramps) when used with over-the- counter pain medication.
For WL-2405H(M)
The WL-2405H(M) is designed for symptomatic relief and management of chronic pain and provides temporary relief from sore and aching muscles in the shoulders, waist, back, neck, upper extremities (arms), and lower extremities (legs) due to strain from exercise or daily activities. It also offers temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication.
Additionally, the WL-2405H(M) features EMS functionality for stimulating healthy muscles to enhance or facilitate muscle performance (select EMS modes). It also provides symptomatic relief and management of chronic, intractable pain and relief from pain associated with arthritis (select TENS mode P8).
4. Description of the Device:
The Well-Life Pain relief (Menstrual Plus) Electrical Stimulator is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower (extremities) leg due to strain from exercise or normal household work activities. It also provides symptomatic relief and management of chronic, intractable pain and relief from pain associated with arthritis This stimulator should be applied to the normal, healthy, dry, and clean skin of adult patients with the aim of stimulating healthy muscles and enhancing muscle performance.
There are three available models: WL-2405H(M), WL-2315E(M), and WL-2315C(M). WL-2405H(M) is derived from the WL-2405H (FDA 510K no. K172809) with modifications. It includes the original TENS modes P1-P8 and EMS modes P1-P6, along with two additional TENS modes (P9, P10). TENS P9 is used for Pain Relief/Menstrual pain relief, while TENS P10 is suitable for Pain Relief. The WL-2405H(M) model offers 16 preset modes, with 10 modes for TENS (Transcutaneous Electrical Nerve Stimulation) and 6 modes for EMS (Electrical Muscle Stimulation). It features an LCD/LED display and a user-friendly interface that allows for adjustments to preset modes, output signal intensity, and treatment duration. It also includes two output channels.
The WL-2315E(M)/WL-2315C(M) model is a distinct version that exclusively focuses on the TENS P9 mode for dysmenorrhea pain relief, derived from the WL-2405H(M) model. This series of products is an adaptation of the mini-TENS stimulator.
(wl-23xxc/wl-23xxe series) family (FDA 510K no. K220524), with identical external design and internal components, software, etc., with the only modification being the Output Signal. This model has three buttons for power on/off and intensity adjustment and is intended for use with the specified preset mode, providing relief for chronic pain and sore muscles in various body areas. It is for alleviating pain associated with dysmenorrhea (menstrual cramps).
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Image /page/7/Picture/0 description: The image shows the logo for Well-life, a healthcare products company. The logo features a yellow butterfly shape on the left side. The company name "well-life" is written in blue text to the right of the butterfly. Below the company name, the tagline "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" is written in smaller blue text.
The Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator must be used with 510K cleared Electrode pads (K082065) and Garment electrodes (K200942). These accessories are available for purchase along with the device or separately as supplementary packs.
5. Non-Clinical Performance Testing:
Non-clinical testing was conducted to verify that the subject devices met all design specifications, demonstrated safety based on current industry standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed:
-
- Sterilization and Shelf Life
To demonstrate the adequacy of the shelf life, the recommended study process for the similar product released on guidance document FDA-2020-D-0957 "Shelf Life of Medical Devices" and ASTM F1980-16 "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices "is followed. After test and study, the shelf life for electrodes to be used with the device is 2 years.
- Sterilization and Shelf Life
-
- Software Validation
The FDA guidance document titled "General Principles of Software Validation: Final Guidance for Industry and FDA Staff"issued on 11/05/2005" was used to validate software used in the device. Required documentation was provided in accordance with this guidance document.
- Software Validation
-
- Electromagnetic compatibility and electrical safety
Testing was performed to verify the electromagnetic compatibility and electrical safety of the subject device using the following standards:
- Electromagnetic compatibility and electrical safety
-
(1) IEC60601-1: General requirements for basic safety and essential performance
(2) IEC-60601-1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
(3) IEC-60601-1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
(4) IEC-60601-2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
(5) Bench testing was performed to verify the output parameter specifications of the device using the AAMI NS4(2013) standard for Transcutaneous Electrical Nerve Stimulators
5) Clinical Testing Performance Testing
No clinical performance testing was conducted or necessary for this device and indications for use.
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Image /page/8/Picture/0 description: The image shows the logo for "well-life", a company that produces healthcare products. The logo features a yellow butterfly with the company name written in blue text. Below the company name is the tagline "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in smaller, blue text. The logo is simple and clean, and the butterfly is a symbol of transformation and hope.
7. Substantial Equivalence Discussion:
7.1 Substantial Equivalence Comparison to Predicate Device
| Attribute | Subject Device | Primary Predicate Device: | Secondary Predicate Device: | Comparison |
|---|---|---|---|---|
| Product Name | The Well-Life Pain relief | |||
| (Menstrual Plus) Electrical | ||||
| Stimulator | OTC Combo TENS/EMS | |||
| System | Livia | |||
| Model | WL-2405H(M), WL-2315E(M), | |||
| WL-2315C(M) | WL-2405H, WL-2405G | --- | ||
| Manufacture | Well-life Healthcare | Well-life Healthcare | Life-Care Ltd. | |
| 510(K) number | Applying | K172809 | K183110 | |
| Product Code | NUH, NGX, NYN | NUH, NGX, NYN | NUH | Identical |
| Regulation No. | 882.5890 | 882.5890 | 882.5890 | Identical |
| Main function | 1. TENS | |||
| General Pain/ Menstrual pain | ||||
| relief/for WL-2405H(M) |
- EMS | 1. TENS
(General Pain/) - EMS | TENS
(General Pain/ Menstrual pain
relief) | Note. 1 |
| Indications for Use | The Well-Life Pain Relief
(Menstrual Plus) Electrical
Stimulator includes three
models: WL- 2315C(M),
WL-2315E(M), and
WL-2405H(M). The
indications for use are as
follows:
For WL-2315C(M) and WL-
2315E(M) | For temporary relief of pain associated
with sore and aching muscles in the
lower back due to strain from exercise
or
normal household and work activities.
(Choose TENS Modes P1 through P7)
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 | The Livia is designed for
symptomatic relief and
management of chronic pain,
and for temporary relief of
pain associated with sore and aching
muscles in the shoulder, waist, back,
neck, upper extremities (arm) and
lower (extremities) leg due to strain
from exercise or normal household
work activities and for temporary relief
of pain associated with dysmenorrhea
(menstrual cramps) when used with
OTC pain medication | |
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Image /page/9/Picture/0 description: The image shows a logo for "well-life" with the tagline "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING". The logo features the text "well-life" in a stylized font, with the word "well" stacked above "life". To the left of the text is a yellow butterfly. The tagline is written in smaller letters below the company name.
| The WL-2315C(M) and WL-
2315E(M) are designed for the
symptomatic relief and
management of pain. They
offer temporary relief from
pain associated with
dysmenorrhea (menstrual
cramps) when used with over-
the- counter pain medication.
For WL-2405H(M)
The WL-2405H(M) is designed
for symptomatic relief and
management of chronic pain
and provides temporary relief
from sore and aching muscles
in the shoulders, waist, back,
neck, upper extremities (arms),
and lower extremities (legs) due
to strain from exercise or daily
activities. It also offers
temporary relief of pain
associated with dysmenorrhea
(menstrual cramps) when used
with over-the-counter pain
medication.
Additionally, the WL-
2405H(M) features EMS
functionality for stimulating
healthy muscles to enhance or
facilitate muscle performance
(select EMS modes). It also
| provides symptomatic relief and | ||
|---|---|---|
| management of chronic, | ||
| intractable pain and relief from | ||
| pain associated with arthritis | ||
| (select TENS mode P8). |
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Image /page/10/Picture/0 description: The image shows the logo for Well-life. The logo features a yellow butterfly with the words "well-life" in blue text over the butterfly. Below the company name is the text "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING".
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Image /page/11/Picture/0 description: The image shows the logo for Well-Life. The logo features a yellow butterfly with the words "well-life" in blue text superimposed on the butterfly's wing. Below the company name is the text "SMARTER HEALTHCARE PRODUCTS FOR BETTER LIVING" in smaller, black font.
| Attribute | Subject Device | Primary Predicate Device: | Secondary Predicate Device: | Comparison |
|---|---|---|---|---|
| activities. (Choose TENS Modes P1 | ||||
| through P7) | ||||
| For symptomatic relief and | ||||
| management of chronic, intractable | ||||
| pain and relief of pain associated with | ||||
| arthritis. (Choose | ||||
| TENS Mode P8) | ||||
| For use by healthy adults for the | ||||
| stimulation of healthy muscles in order | ||||
| to improve or facilitate muscle | ||||
| performance. | ||||
| (Choose EMS Modes P1 through P6 | ||||
| Prescriptive or OTC | OTC | OTC | OTC | Identical |
| Number of output modes | WL-2315E(M), WL-2315C(M) | |||
| 1 mode for TENS | ||||
| WL-2405H(M) | ||||
| TENS: 10+EMS: 6 | TENS: 8 | |||
| EMS: 6 | 1 | Note. 2 | ||
| Power Source(s) | 3.7V Lithium-Ion Battery | 3.7V Lithium-Ion Battery | 3.7V Lithium-Ion Battery | Identical |
| Method of Line Current | ||||
| Isolation | Output is electrically disabled | |||
| when connect to charger, by | ||||
| Output is electrically disabled | ||||
| when connect to charger, by | ||||
| Identical 4-6 means of | ||||
| microprocessor charging circuit | Output is electrically disabled | |||
| when connect to charger, by | ||||
| Output is electrically disabled | ||||
| when connect to charger, by | ||||
| Identical 4-6 means of | ||||
| microprocessor charging circuit | Output is electrically disabled | |||
| when connect to charger, by | ||||
| Output is electrically disabled | ||||
| when connect to charger, by | ||||
| Identical 4-6 means of | ||||
| microprocessor charging circuit | Identical | |||
| Patient Leakage Current |
- Normal Condition (μΑ) | Battery powered (