(149 days)
Not Found
Not Found
No
The summary describes a TENS/PMS device with standard pain relief and muscle stimulation modes. There is no mention of AI, ML, image processing, or any data-driven algorithms typically associated with AI/ML in medical devices.
Yes
The device is intended for the temporary relief of pain associated with sore and aching muscles, symptomatic relief and management of chronic pain, and relief of pain associated with arthritis, which are therapeutic applications. It also aims to stimulate healthy muscles for improvement of muscle tone and firmness, strengthening muscles, and temporarily increasing local blood circulation, which, despite a disclaimer about therapy or medical conditions for PMS modes, contribute to its overall therapeutic nature.
No
Explanation: The "Intended Use / Indications for Use" section describes the device's purpose for pain relief and muscle stimulation, not for diagnosing medical conditions.
No
The intended use describes a TENS and PMS device, which are hardware-based electrical stimulation devices. The summary does not mention any software component or describe the device as software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a TENS/PMS unit for pain relief and muscle stimulation. These are external applications to the body and do not involve testing samples taken from the body (like blood, urine, or tissue) to diagnose or monitor a medical condition.
- Device Description: While the device description is "Not Found," the intended use is the primary indicator of whether a device is an IVD.
- Other Sections: The absence of information in sections like "Mentions image processing," "Mentions AI, DNN, or ML," "Input Imaging Modality," and details about training/test sets further supports that this is not an IVD, as these are often relevant for diagnostic devices, especially those using advanced technologies.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely external and therapeutic/stimulatory.
N/A
Intended Use / Indications for Use
TENS (Modes 1, 2, 4, 5, 6)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, arm, and leg, due to strain from exercise or normal household and work activities.
It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
PMS (Modes 1 and 3)
To stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
It is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
Product codes
NUH, NGX, NYN
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, arm, and leg; arms, abdomen, legs, and buttocks; lower extremities
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)
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 seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 5, 2016
JKH Health Co., Ltd. % Bill Quanqin Dai, Ph.D. Application Correspondent 1142 S. Diamond Bar Blvd. #861 Diamond Bar, CA 91765
Re: K153520
Trade/Device Name: Electronic Pulse Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX, NYN Dated: March 30, 2016 Received: April 5, 2016
Dear Dr. Dai:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 yours,
Michael J.Hoffmann -A
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) K153520
Device Name Electronic Pulse Stimulator
Indications for Use (Describe)
TENS (Modes 1, 2, 4, 5, 6)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, arm, and leg, due to strain from exercise or normal household and work activities.
It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
PMS (Modes 1 and 3)
To stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
It is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
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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