(113 days)
Not Found
Not Found
No
The provided text describes a TENS/EMS device and its intended uses. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The "Not Found" entries for sections related to AI/ML training/testing further support this conclusion.
Yes
The device description, based on its intended use/indications for use, states that it is a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulation (EMS) device used for relieving chronic pain and various muscle-related issues, which are therapeutic applications.
No
The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS) and an Electrical Muscle Stimulation (EMS) device, which are used for symptomatic relief, muscle rehabilitation, and pain management, not for diagnosing medical conditions.
No
The intended use describes a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulation (EMS) device, which are hardware-based devices that deliver electrical impulses. The summary does not mention any software-only component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are for symptomatic relief of pain, muscle relaxation, preventing atrophy, increasing blood circulation, re-educating muscles, and maintaining range of motion. These are all therapeutic applications, not diagnostic ones.
- Device Description: While the description is "Not Found," the intended use clearly points away from in vitro diagnostics.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
In vitro diagnostics are devices used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device, a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS), is used for direct therapeutic intervention on the body.
N/A
Intended Use / Indications for Use
Transcutaneous Electrical Nerve Stimulator (TENS) can be used for the following applications (Available for WR-2603/2603A, and TENS function of WR-2605/ 2605A):
- For symptomatic relief of chronic intractable pain
Electrical Muscle Stimulation (EMS) on can be used for the following applications (Available for WR-2604/2604A, and EMS function of WR-2605/ 2605A):
- Relax muscle spasms
- Prevent or retard disuse atrophy
- Increase local blood circulation
- Re-educate muscles
- Maintain or increase the range of motion
Product codes
GZJ, IPF
Device Description
Not Found
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
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/1 description: The image shows the logo for the U.S. Department of Health & 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 an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 17, 2017
Well-life Healthcare Limited Chin-Chih Hsieh Official Correspondent 1f, No. 16, Lane 454, Jungjeng Road Yunghe District, New Taipei City, 234 TW
Re: K162663
Trade/Device Name: WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZJ, IPF Dated: December 8, 2016 Received: December 12, 2016
Dear Chin-Chih 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. 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.
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
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
MichaelJ. Hoffmann -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
Enclosure
2
Indications for Use
510(k) Number (if known) K162663
Device Name
WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A
Indications for Use (Describe)
Transcutaneous Electrical Nerve Stimulator (TENS) can be used for the following applications (Available for WR-2603/2603A, and TENS function of WR-2605/ 2605A):
· For symptomatic relief of chronic intractable pain
Electrical Muscle Stimulation (EMS) on can be used for the following applications (Available for WR-2604/2604A, and EMS function of WR-2605/ 2605A):
- · Relax muscle spasms
- Prevent or retard disuse atrophy
- Increase local blood circulation
- · Re-educate muscles
- · Maintain or increase the range of motion
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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