(234 days)
No
The device description and performance studies focus on basic electrical stimulation parameters and comparison to predicate devices based on power output, not on any adaptive or learning capabilities. There is no mention of AI, ML, or any related concepts.
Yes
The device is described as an "OTC TENS" intended for "temporary relief of pain associated with sore and aching muscles," which falls under the definition of a therapeutic device.
No
The device is described as an OTC TENS unit intended for temporary relief of pain associated with sore and aching muscles. It provides therapeutic electrical stimulation rather than diagnosing a medical condition.
No
The device description clearly outlines hardware components such as a battery-operated TENS device, electrodes (upper arm belt, snap type adhesive electrode), and an LCD display. It also mentions adjustable output strength and pre-programmed waveforms, indicating hardware-controlled 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 "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." This describes a therapeutic purpose, not a diagnostic one.
- Device Description: The description details a TENS (Transcutaneous Electrical Nerve Stimulation) device, which delivers electrical impulses to the body for pain relief. This is a physical therapy modality, not a method for analyzing samples from the body to diagnose a condition.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
The device is clearly described as a TENS unit for pain relief, which falls under the category of physical medicine or therapeutic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The OTC TENS for Arm & Leg Pain Relief / model WL-2407 is 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
The Well Life TENS devices, WL-2407 is the model of OTC TENS 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. Basically the stimulation model WL-2407 is completely identical to that of model as mentioned in the Well-Life K063660- 510(K) cleared device. To change the indication for use for the treatment location as the chosen predicate devices. Well-Life change the design of electrode.
For the device included in this submission, we use the following third party 510(K) legally marketed predicate components: K022494, the Home Care Jelly.
WL-2407 is a selectable dual channel, 4.5V (3xAAA/Alkaline battery) operated TENS device with the following features:
- The operation function is dual channels completely identical to the model being modified, WL-2407 for low back pain relief(K063660).
- For the stimulation electrode. Well-Life uses upper arm belt as well as snap type adhesive electrode as standard accessories.
- The output waveform is selectable pre-programming change among P1~P8.
- The output strength is adjustable at 0~80 mA, with setting time 21 minutes counting from switchina ON.
- The LCD display is provided for the indication of operation status including operation mode, output program mode, output intensity, time to cut-off, and battery low warning.
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)
Indicated Patient Age Range
Not Found
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
Power level testing comparison was conducted with the Prizm 5000-Z system using 1K ohm loading resistance for garment electrodes. The comparison showed that the model WL-2407 has a lower output power and power density than the Prizm 5000-Z system. Non-clinical tests were performed to determine substantial equivalence, including compliance to ANSI/AAMI, NS4-1985, EN 60601-1, and EN 60601-1-2 requirements. Verification and validation tests demonstrated that the differences in the submitted model maintain the same safety and effectiveness as the cleared device.
Key Metrics
Current comparison:
| Electrode Type | Well-life WL-2407 (mA/cm4) | Prizm 5000-Z (mA/cm4) |
|---|---|---|
| Glove | 0.00337 | 0.00340 |
| Sleeve& Knee | 0.00386 | 0.00385 |
| Sock | 0.00271 | 0.00274 |
| Silicone Pad | 0.11728 | 0.11817 |
Power Density Comparison:
| Electrode Type | Well-life WL-2407 (W/cm-) | Prizm 5000-Z (W/cm-) |
|---|---|---|
| Glove | 0.00032 | 0.00064 |
| Sleeve & Knee | 0.00036 | 0.00072 |
| Sock | 0.00025 | 0.00051 |
| Silicone Pad | 0.01098 | 0.02222 |
Predicate Device(s)
Reference Device(s)
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
5)0(k):
510(K) Summary
FEB - 5 2010
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K091757 .
-
- Submitter's Identifications: Well Life Healthcare Limited 1F., No. 16, Lane 454, Jungjeng Road, Yunghe City, Taipei County 23455, Taiwan, ROC
Contact: Jenny Hsieh
- Submitter's Identifications: Well Life Healthcare Limited 1F., No. 16, Lane 454, Jungjeng Road, Yunghe City, Taipei County 23455, Taiwan, ROC
Date of Summary Preparation: December 08, 2009
-
- Name of the Device:
OTC TENS for Arm & Leg Pain Relief / Model: WL-2407.
- Name of the Device:
-
- Device Description:
The Well Life TENS devices, WL-2407 is the model of OTC TENS 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. Basically the stimulation model WL-2407 is completely identical to that of model as mentioned in the Well-Life K063660- 510(K) cleared device. To change the indication for use for the treatment location as the chosen predicate devices. Well-Life change the design of electrode.
For the device included in this submission, we use the following third party 510(K) legally marketed predicate components: K022494, the Home Care Jelly.
WL-2407 is a selectable dual channel, 4.5V (3xAAA/Alkaline battery) operated TENS device with the following features:
- The operation function is dual channels completely identical to the model being modified, WL-2407 for low back pain relief(K063660).
- For the stimulation electrode. Well-Life uses upper arm belt as well as snap type adhesive electrode as standard accessories.
- The output waveform is selectable pre-programming change among P1~P8.
- The output strength is adjustable at 0~80 mA, with setting time 21 minutes counting from switchina ON.
- The LCD display is provided for the indication of operation status including operation mode, output program mode, output intensity, time to cut-off, and battery low warning.
1
5. Intended Use:
The OTC TENS for Arm & Leg Pain Relief / model WL-2407 is 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
The standard format for the statement of indications and contraindication for use are provided hereafter.
6. Power level testing comparison and acknowledge of comparison result with Prizm 5000Z system:
For the substantial equivalent comparison, the power level testing comparison with the chosen 510(K) cleared device, Prizm 5000-Z system was conducted via using 1K ohm loading resistance for the garment electrodes . Testing set up with comparison result is as the following table :
Current comparison: (Unit: mA/cm4)
| Electrode Type | Glove | Sleeve& Knee | Sock | Silicone Pad |
|---|---|---|---|---|
| Well-life WL-2407 | 0.00337 | 0.00386 | 0.00271 | 0.11728 |
| Prizm 5000-Z | 0.00340 | 0.00385 | 0.00274 | 0.11817 |
Power Density Comparison : (Unit: W/cm-)
| Electrode Type | Glove | Sleeve & Knee | Sock | Silicone Pad |
|---|---|---|---|---|
| Well-life WL-2407 | 0.00032 | 0.00036 | 0.00025 | 0.01098 |
| Prizm 5000-Z | 0.00064 | 0.00072 | 0.00051 | 0.02222 |
Based on this comparison result, we made a acknowledge that the model WL-2407 has a lower output power and power density than that of Prizm 5000-Z system while using the same electrode, and that the garment electrode for prescription use will not be packed or sold with WL-2407 model. In case the garment electrode is to be used with WL-2407 model , the effectiveness is to be determined by the physician who prescribes the use of that electrode.
7 . Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes ANSI/AAMI, NS4-1985, as well as EN 60601-1, and EN 60601-1-2 requirement.
8. Conclusions
The OTC TENS for Arm & Leg Pain Relief / model WL-2407 has the same intended use and the similar technological characteristics as the cleared device of Prizm 5000-Z system (K033122) and Endurance Therapeutics T1040 (K060846). Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that
2
the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device.
In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
FEB - 5 2010
Well Life Healthcare Ltd c/o Ms. Jenny Hsieh Official Correspondent 1FL. No. 16. Lane 454 Jungjeng Rd. Yunghe City, Taipei County China (Taiwan) 234
Re: K091757
Trade/Device Name: OTC TENS For Arm & Leg Pain Relief / Model WL-2407 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: II Product Code: NUH Dated: December 10, 2009 Received: December 11, 2009
Dear Ms. 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. The The The The The The The The The The The The The The The The The The The 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.
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Kesia Alexander for
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications For Use
510(k) Number (if known): K091757
Device Name: OTC TENS For Arm & Leg Pain Relief / Model WL-2407.
Indications For Use:
- The OTC TENS for Arm & Leg Pain Relief / model WL-2407 are 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.
Prescription Use (Part 21 CFR 801 Subpart D)
OR
Over-The-Counter Use V (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K091757