(316 days)
Not Found
Not Found
No
The provided text describes a therapeutic ultrasound and TENS device with standard indications for use. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The lack of information on device description, performance studies, or data sets further supports the conclusion that AI/ML is not incorporated.
Yes
The "Intended Use / Indications for Use" section explicitly states therapeutic applications such as "Pain relief," "Reduction of muscle spasm," and "Symptomatic relief of chronic intractable pain."
No
The "Intended Use / Indications for Use" section describes therapeutic purposes (pain relief, muscle spasm reduction, increased blood flow) and pain management, not diagnosis. The functions listed are treatments, not methods for identifying a disease or condition.
No
The 510(k) summary describes a therapeutic ultrasound and transcutaneous electrical nerve stimulation (TENS) device. Both of these modalities inherently involve hardware components (ultrasound transducers, electrodes, power sources) to deliver the therapy. The summary does not mention any software-only functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (pain relief, muscle spasm reduction, joint contractures, increased blood flow, symptomatic pain relief) are all therapeutic applications. IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: While the description is "Not Found," the intended use clearly points to a device that interacts with the body for treatment, not for analyzing biological samples.
- Lack of IVD-related information: The absence of information about sample types, analytical methods, or diagnostic outputs further supports that this is not an IVD.
This device appears to be a therapeutic device combining ultrasound and TENS technologies.
N/A
Intended Use / Indications for Use
Therapeutic Ultrasound: 1) Pain relief; 2) Reduction of muscle spasm; 3) Joint contractures: 4) Localized increase in blood flow. Transcutaneous Electrical Nerve Stimulation: 1) Symptomatic relief of chronic intractable pain 2)Post-traumatic pain 3)Post-surgical pain
Product codes
IMI, GZJ
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
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
§ 890.5300 Ultrasonic diathermy.
(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Auqust 26, 2015
Shenzhen Dongdixin Technology Co., Ltd Qilian Liu R.A. Director No. 3 Building, XiLiBaimang Industrial Estate Nanshan District Shenzhen, 518108 Guangdong CHINA
Re: K142976
Trade/Device Name: UltraTENS Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic diathermy Regulatory Class: Class II Product Code: IMI, GZJ Dated: July 27, 2015 Received: July 27, 2015
Dear Qilian Liu,
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Carlos L. Pena -S
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) K142976
Device Name UltraTENS
Indications for Use (Describe)
Therapeutic Ultrasound:
-
Pain relief;
-
Reduction of muscle spasm;
-
Joint contractures:
-
Localized increase in blood flow.
Transcutaneous Electrical Nerve Stimulation: 1) Symptomatic relief of chronic intractable pain 2)Post-traumatic pain 3)Post-surgical pain
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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