(162 days)
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.
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.
This document is a 510(k) summary for the Well-Life Mini TENS Stimulator, which is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief. The purpose of this summary is to demonstrate substantial equivalence to a legally marketed predicate device, not to present a de novo clinical study with specific acceptance criteria in the typical sense for an AI/ML device.
Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (such as sensitivity, specificity, or AUC) is not applicable to this submission. This 510(k) summary is for a medical device that relies on established TENS technology and demonstrates substantial equivalence through non-clinical bench testing, biocompatibility testing, and comparisons to predicate devices based on technical specifications and safety standards.
The document explicitly states: "No clinical testing was conducted for this device." This means there was no study performed to measure the device's performance against clinical endpoints or to assess how it might improve human reader performance with AI assistance. As such, there are no acceptance criteria, sample sizes, expert ground truth establishment, or adjudication methods as would be found in a study for an AI/ML algorithm requiring such validation.
Instead, the "acceptance criteria" for this device's clearance were its adherence to relevant electrical safety, biocompatibility, and performance standards for TENS devices, and its demonstrated substantial equivalence (based on design, intended use, energy type, etc.) to already cleared predicate devices.
Here's a breakdown of the information that is available in the document, framed against your request, highlighting why some points are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a TENS device relying on substantial equivalence to predicates, the "acceptance criteria" are compliance with relevant safety and performance standards for TENS devices and demonstrating that its specifications are similar to or justify differences from the predicate. The "reported device performance" are the results of non-clinical bench testing and adherence to these standards.
| Acceptance Criteria (based on standards & predicate comparison) | Reported Device Performance / Compliance |
|---|---|
| Biocompatibility (ISO 10993-1, -5, -10) | In compliance, no concerns |
| Electrical Safety (IEC 60601-1, -1-2, -1-11, -2-10) | Met all design specifications |
| Battery Safety (IEC 62133) | Met all design specifications |
| Performance Bench Testing (IEC 60601-2-10, ANSI AAMI NS4) | Met all design specifications |
| Usability Engineering (IEC 60601-1-6, IEC 62366-1) | Met all design specifications |
| Risk Management (ISO 14971) | Applied |
| Device Specifications vs. Primary Predicate (K121353) | (See tables on pages 9-13) |
| Regulation Number (882.5890) | Same |
| Product Code (NUH) | Same |
| OTC/Rx | Same (OTC) |
| Indication for use | Same |
| Method of Line current Isolation (Type BF) | Same |
| Patient Leakage Current (Normal |
§ 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).