(202 days)
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No
The summary does not mention AI, ML, or any related concepts like image processing, deep learning, or training/test sets, which are typically associated with AI/ML-powered medical devices. The description focuses on the core function of TENS technology.
Yes
The "Intended Use / Indications for Use" explicitly states that the TENS system is "designed for the treatment of pain." This indicates a medical purpose to treat a condition, classifying it as a therapeutic device.
No
Explanation: The device is described as a "pain management unit" for treating pain, not for diagnosing it.
Unknown
The provided text only describes the intended use of a TENS system, which is a hardware device. There is no information about the device description or any mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "Transcutaneous Electrical Nerve Stimulation" unit designed for "treatment of pain". This describes a therapeutic device that interacts with the patient's body externally.
- Lack of IVD Characteristics: The description does not mention any of the key characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on in vitro analysis.
- Using reagents or other materials for testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This TENS device is a therapeutic device that delivers electrical stimulation to the body for pain management.
N/A
Intended Use / Indications for Use
TENS stands for Transcutaneous Electrical Nerve Stimulation and is a non-invasive and drugfree pain management unit. The TENS system is designed for the treatment of pain - chronic, acute or post-operative pain.
Product codes
GZJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 0 6 2000
Mr. Toru Horiuchi Sales Manager Fuji Dynamics, Ltd Unit 1-3, 23/F., Laws Commercial Plaza 788 Cheung Sha Wan Road, Kowloon, Hong Kong
Re: K994266
Trade Name: FDTENS 2010 Regulatory Class: II Product Code: GZJ Dated: April 7, 2000 Received: April 10, 2000
Dear Mr. Horiuchi:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Toru Horiuchi
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4689. Also, please note the regulation entitled, "Misbranding by reference to premarket notification (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Duane R. Lochner.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number Device Name
K994266 FDTENS 2010
Indications for Use
TENS stands for Transcutaneous Electrical Nerve Stimulation and is a non-invasive and drugfree pain management unit. The TENS system is designed for the treatment of pain - chronic, acute or post-operative pain.
Concurrence of CDRH, Office of Device Evaluation
| R. Vochner | |
|---|---|
| Division Sign-Off | |
| ion of General Restorative Devic | |
| Number K994266 |
| Prescription Use | X | Or | Over-the-Counter-Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |