(136 days)
WL-2402 (K020020)
No
The description focuses on standard electrical stimulation parameters and user-selectable pre-programmed waveforms, with no mention of adaptive algorithms, learning, or AI/ML terminology.
Yes
The device is a transcutaneous electrical nerve stimulator (TENS device) intended for symptomatic relief of chronic intractable pain, which is a therapeutic purpose.
No
Explanation: The device is described as a transcutaneous electrical nerve stimulator (TENS device) intended for "symptomatic relief of chronic intractable pain." Its function is to deliver electrical stimulation, not to diagnose medical conditions or analyze patient data for diagnostic purposes.
No
The device description explicitly details hardware components such as batteries, wires, electrodes, and an LCD display, indicating it is a physical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "symptomatic relief of chronic intractable pain." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a transcutaneous electrical nerve stimulator (TENS device). TENS devices deliver electrical impulses to the body for pain relief.
- Mechanism of Action: The description details how the device delivers electrical stimulation via electrodes. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
In summary, the i. Pro TENS; model WL-2407Rx is a therapeutic device used for pain management, not a diagnostic device used to test samples from the body.
N/A
Intended Use / Indications for Use
The model WL-2407Rx TENS is a portable, battery-powered, transcutaneous electrical nerve stimulator (TENS device) that is intended for symptomatic relief of chronic intractable pain.
The i. Pro TENS; model WL-2407Rx is a portable, battery-powered, transcutaneous electrical nerve stimulator (TENS device) that is intended for symptomatic relief of chronic intractable pain.
Product codes
GZJ
Device Description
The Well Life TENS devices, WL-2407Rx is the model of prescription TENS intended for symptomatic relief of chronic intractable pain.
WL-2407Rx is a selectable dual channel, 4.5V (3xAA/Alkaline battery) operated TENS device with the following features:
- The operation of device is via the connection of wire and electrode through the dual operation channels.
- The stimulation electrode includes adhesive electrode and garment electrode. It may be chosen depending upon the prescription of physician.
- The output waveform is selectable pre-programming change among P1-P6.
- The output strength is adjustable at 0
80 mA, with setting time 560 minutes counting from switching ON. - The LCD display is provided for the indication of operation status including operation mode, output wave form, output strength, 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D) OR Over-The-Counter Use (21 CFR 807 Subpart C)
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)
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.
In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance.
The i. Pro TENS/ model WL-2407Rx has the same intended use and the similar technological characteristics as the cleared device of WL-2402 (K020020). Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
WL-2402 (K020020)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
510(K) Summary
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: _ _ 080304
-
- Submitter's Identifications: Well-Life Healthcare Limited 1FL., No. 16, Lane 454, Jungjeng Rd., Yunghe City, Taipei County, Taiwan, R.O.C.
Contact: Jenny Hsieh Phone No .: 886-2-2928-2112 Fax No.: 886-2-2928-1880 e-mail: jenny@welllifehealthcare.com.tw
- Submitter's Identifications: Well-Life Healthcare Limited 1FL., No. 16, Lane 454, Jungjeng Rd., Yunghe City, Taipei County, Taiwan, R.O.C.
Date of Summary Preparation: February 05, 2008
-
- Name of the Device:
i. Pro TENS / Model: WL-2407Rx.
- Name of the Device:
-
- Information of the 510(k) Cleared Device (Predicate Device):
WL-2402 (K020020)
- Information of the 510(k) Cleared Device (Predicate Device):
4. Device Description:
The Well Life TENS devices, WL-2407Rx is the model of prescription TENS intended for symptomatic relief of chronic intractable pain.
WL-2407Rx is a selectable dual channel, 4.5V (3xAA/Alkaline battery) operated TENS device with the following features:
- The operation of device is via the connection of wire and electrode through the dual operation channels.
- The stimulation electrode includes adhesive electrode and garment electrode. It may be chosen depending upon the prescription of physician.
- The output waveform is selectable pre-programming change among P1-P6.
- The output strength is adjustable at 0
80 mA, with setting time 560 minutes counting from switching ON. - The LCD display is provided for the indication of operation status including operation mode, output wave form, output strength, time to cut-off, and battery low warning.
1
5. Intended Use:
The model WL-2407Rx TENS is a portable, battery-powered, transcutaneous electrical nerve stimulator (TENS device) that is intended for symptomatic relief of chronic intractable pain.
The standard format for the statement of indications and contraindication for use are provided hereafter.
6. 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.
In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance.
7. Conclusions
The i. Pro TENS/ model WL-2407Rx has the same intended use and the similar technological characteristics as the cleared device of WL-2402 (K020020). Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that 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.
Therefore; i. Pro TENS model WL-2407Rx is considered substantial equivalent to the 510(K) cleared model WK-2402(K020020).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with flowing lines, representing the department's mission of protecting and promoting the health and well-being of Americans. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 0 2008
Well-Life Healthcare Limited % Ms. Jenny Hsieh 1FL., No. 16, Lane 454 Jungjeng Rd. Yunghe City, Taipei County, Taiwan, R.O.C.
Re: K080304
Trade/Device Name: Pro TENS, Model WL-2407 Rx Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: May 21, 2008 Received: June 4, 2008
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 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 such 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 r touse of acreased 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 or any x with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rordly in the quality by eventy of Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Jenny Hsieh
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Mark M. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
510(k) Number (if known):
Device Name: i. Pro TENS / Model WL-2407Rx.
Indications For Use:
The i. Pro TENS; model WL-2407Rx is a portable, battery-powered, transcutaneous electrical nerve stimulator (TENS device) that is intended for symptomatic relief of chronic intractable pain.
Prescription Use (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (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)
Nifke Dsh forman
(Division Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number K080304