(250 days)
Not Found
Not Found
No
The summary does not contain any mentions of AI, ML, DNN, image processing, or descriptions of training/test sets, which are common indicators of AI/ML technology in medical devices. The device description is also not available.
Yes
The device is described as providing "temporary relief of pain" and is intended "to stimulate healthy muscles in order to improve and facilitate muscle performance," which aligns with the definition of a therapeutic device.
No
Explanation: The device is intended for pain relief and muscle stimulation, which are therapeutic uses, not diagnostic. It does not identify or investigate diseases or conditions.
No
The intended use describes Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS), which are modalities that require hardware (electrodes, stimulator unit) to deliver electrical impulses. The summary does not mention the device being software that controls or analyzes data from a separate hardware device; it describes the function of the hardware itself.
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 as a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS). These are devices that apply electrical stimulation to the body for pain relief and muscle stimulation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any such activities. The device interacts directly with the body.
Therefore, this device falls under the category of a therapeutic or physical medicine device, not an IVD.
N/A
Intended Use / Indications for Use
Transcutaneous Electrical Nerve Stimulation (TENS): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. Powered Muscle Stimulation (PMS): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Product codes
NGX, NUH
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, back, neck, upper extremities (arm), and lower extremities (leg)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 21, 2015
Shenzhen As-tec Technology Co., Ltd % Doris Dong Manager Shanghai Cv Technology Co., Ltd Room 1706 Yuesha Building, No.128 Songle Rd., Songjiang Area Shanghai. 201600 CN
Re: K143268
Trade/Device Name: TENS and Powered Muscle Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, NUH Dated: September 26, 2014 Received: November 13, 2014
Dear Doris Dong,
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 yours,
Michael J.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) K143268
Device Name TENS and Powered Muscle Stimulator
Indications for Use (Describe)
Transcutaneous Electrical Nerve Stimulation (TENS):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
Powered Muscle Stimulation (PMS):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
| 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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