(61 days)
No
The summary describes a standard TENS device with selectable pre-programmed waveforms and adjustable intensity. There is no mention of AI or ML in the device description, intended use, or performance studies. The software verification mentioned is standard for medical devices and does not imply AI/ML.
Yes
The device is intended for "temporary relief of pain associated with sore and aching muscles," which is a therapeutic purpose.
No
The description explicitly states its purpose is for "temporary relief of pain" and mentions "output waveform," "output strength," and "stimulation electrode," which are characteristics of a therapeutic device (specifically a TENS unit), not a diagnostic one. There is no mention of identifying or characterizing a medical condition.
No
The device description explicitly details hardware components such as batteries, electrodes, adjustable output strength in mA, and an LCD display, indicating it is a physical device with embedded software, not a standalone software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided description clearly states that the WL-2407 is a TENS (Transcutaneous Electrical Nerve Stimulation) device. TENS devices deliver electrical impulses through the skin to relieve pain.
- Intended Use: The intended use is for "temporary relief of pain associated with sore and aching muscles in the lower back." This is a therapeutic use, not a diagnostic one.
- Mechanism of Action: TENS devices work by stimulating nerves, not by analyzing biological samples.
The information provided about the device's features, performance studies (compliance to standards, software verification), and predicate devices all align with a therapeutic electrical stimulation device, not an IVD.
N/A
Intended Use / Indications for Use
The model WL-2407 TENS is intended 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.
The model WL-2407 are intended 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.
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 lower back due to strain from exercise or normal household and work activities.
WL-2407 is a selectable dual channel, 4.5V (3xAA/Alkaline battery) operated TENS device with the following features:
The stimulation electrode is dual channels electrode.
- 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 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
lower back
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
7 2007 FEB
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:
-
- Submitter's Identifications: Well Life Healthcare Limited 5FI., Ste 504, Empire Centre, 68 Mody Road, Tsimshatsuim, Kowloon, Hong Kong
Contact: Jenny Hsieh
- Submitter's Identifications: Well Life Healthcare Limited 5FI., Ste 504, Empire Centre, 68 Mody Road, Tsimshatsuim, Kowloon, Hong Kong
Date of Summary Preparation: January 31, 2007.
2. Name of the Device:
OTC TENS for Low Back Pain Relief / Model: WL-2407.
4. 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 lower back due to strain from exercise or normal household and work activities.
WL-2407 is a selectable dual channel, 4.5V (3xAA/Alkaline battery) operated TENS device with the following features:
The stimulation electrode is dual channels electrode.
- 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 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-2407 TENS is intended 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
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 OTC TENS for low back pain relief/ model WL-2407 has the same intended use and the similar technological characteristics as the cleared device of WL-2402 (K040512), and WL-2406 (K052785). 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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Well-Life Healthcare Limited % Ms. Jenny Hsieh 68 Mody Road, Empire Centre, Suite 504 Tsimshatsuim, Kowloon Hong Kong
7 2007 FEB
Re: K063660
Trade/Device Name: OTC TENS for Low Back 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 6, 2006 Received: December 8, 2006
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 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); 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.
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Page 2 - Ms. Jenny Hseih
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 Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
510(k) Number (if known):
Device Name: OTC TENS For Low Back Pain Relief / Model WL-2407.
Indications For Use:
The model WL-2407 are intended 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.
Prescription Use OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Conci of Of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division of General, Restorative, and Neurological Devices 1063660
510(k) Number_