(90 days)
Not Found
Not Found
No
The summary does not contain any keywords or descriptions related to AI or ML technology. The device is a TENS unit, which typically uses electrical stimulation for pain relief.
Yes
The device is intended for the temporary relief of pain and nausea, which are therapeutic uses.
No
This device is a TENS unit, which is used for pain relief and relief of nausea and vomiting. Its intended uses are therapeutic, not diagnostic.
No
The description explicitly mentions "TENS" models (WL-2402, WL-2403, WL-2401), which are Transcutaneous Electrical Nerve Stimulation devices. TENS devices are hardware-based devices that deliver electrical impulses. The summary does not describe any software component that functions independently as a medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are for pain relief and relief of nausea and vomiting. These are therapeutic applications, not diagnostic tests performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: While the description is "Not Found," the intended use clearly points to a device that interacts with the body externally (TENS - Transcutaneous Electrical Nerve Stimulation).
- No Mention of IVD Activities: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function falls outside of that definition.
N/A
Intended Use / Indications for Use
- The model WL-2402, WL-2403 TENS 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.
- The model WL-2401 TENS is indicated for use in the relief of nausea and vomiting due to motion sickness, and for the relief of mild to moderate nausea and vomiting associated with pregnancy.
Product codes
GZJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower back (for WL-2402, WL-2403)
Not specified directly for WL-2401 but implied to be related to areas affecting nausea and vomiting.
Indicated Patient Age Range
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
MAY 27 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Grace Chang Well-Life Healthcare, Inc. 1FL, No. 16, Lane 454 Jungjeng Rd., Yunghe City Taipei County, Taiwan, R.O.C.
Re: K040512
Trade/Device Name: Models WL-2402, WL-2403 and WL-2401 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: GZJ Dated: May 11, 2004 Received: May 17, 2004
Dear Ms. Chang:
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 cnactment 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 Rcgulations, 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. Grace Chang
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other gencral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Sincerely yours,
Mark A Milliken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Hcalth
Enclosure
2
Indications For Use
510(k) Number (if known): K040512
Device Name: Limited Function WL/OTC-TENS / Model: WL-2401, WL-2402, and WL-2403.
Indications For Use:
- The model WL-2402, WL-2403 TENS 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.
- The model WL-2401 TENS is indicated for use in the relief of nausea and vomiting due to motion sickness, and for the relief of mild to moderate nausea and vomiting associated with pregnancy.
Prescription Use ___________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Mark N. Mulhern
Division of General. Restorative. and Neurological Devices
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510(k) Number K040512