K Number
K172809
Device Name
OTC Combo TENS/EMS System
Date Cleared
2017-10-18

(30 days)

Product Code
Regulation Number
882.5890
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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. (Choose TENS Modes P1 through P7) For temporary relief of pain associated with sore and aching muscles in the upper extremities ( arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P7) For symptomatic relief and management of chromic, intractable pain associated with arthritis. (Choose TENS Mode P8) For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P1 through P6)
Device Description
Not Found
More Information

Not Found

Not Found

No
The summary does not contain any keywords or descriptions related to AI or ML, and the device description is not available.

Yes
The device is described as providing temporary relief of pain associated with sore and aching muscles and for symptomatic relief and management of chronic, intractable pain associated with arthritis, which are therapeutic applications. It also mentions stimulating healthy muscles to improve performance, also a therapeutic claim.

No
Explanation: The device is described for "relief of pain" and "stimulation of healthy muscles," which are therapeutic rather than diagnostic purposes. There is no mention of identifying, classifying, or monitoring a disease or condition.

Unknown

The provided text only describes the intended use and indications for use of the device. It does not contain a device description, which is necessary to determine if the device is software-only or includes hardware components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes the device's purpose as providing temporary relief of pain and stimulating muscles. This is a therapeutic or physical therapy application, not a diagnostic one.
  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform such tests.
  • Lack of Diagnostic Information: The description does not mention any analysis of biological samples or the generation of diagnostic information.

Therefore, this device falls under a different category of medical devices, likely related to pain management or muscle stimulation.

N/A

Intended Use / Indications for Use

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. (Choose TENS Modes P1 through P7)

For temporary relief of pain associated with sore and aching muscles in the upper extremities ( arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P7)

For symptomatic relief and management of chromic, intractable pain associated with arthritis. (Choose TENS Mode P8)

For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P1 through P6)

Product codes

NUH, NYN, NGX

Device Description

OTC Combo TENS/EMS System, model WL-2405G & WL-2405H

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Lower back, upper extremities (arm and/or leg)

Indicated Patient Age Range

Adults

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)

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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 19, 2018

Well-Life Healthcare Limited Chin-Chih Hsieh Official Correspondent 1F, No.16, Lane 454, Jungjeng Road Yunghe Dist, New Taipei City, 234 Tw

Re: K172809

Trade/Device Name: OTC Combo TENS/EMS System Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NYN, NGX Dated: September 15, 2017 Received: September 18, 2017

Dear Chin-Chih Hsieh:

This letter corrects our substantially equivalent letter of October 18, 2017.

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 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

1

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Vivek J. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

2

Indications for Use

510(k) Number (if known) K172809

Device Name

OTC Combo TENS/EMS System, model WL-2405G & WL-2405H

Indications for Use (Describe)

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. (Choose TENS Modes P1 through P7)

For temporary relief of pain associated with sore and aching muscles in the upper extremities ( arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P7)

For symptomatic relief and management of chromic, intractable pain associated with arthritis. (Choose TENS Mode P8)

For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P1 through P6)

Type of Use (Select one or both, as applicable)
---------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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