(90 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other information suggesting the use of AI/ML.
Yes
The "Intended Use / Indications for Use" states that TENS devices are used for "symptomatic relief and management of chronic (long term) intractable pain" and as an "adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems," which describes therapeutic applications.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is for "symptomatic relief and management of chronic (long term) intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems." This describes a therapeutic, not a diagnostic, function.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. The "Intended Use" describes a TENS device, which typically involves hardware for electrical stimulation. Without a description of the device's components, it's impossible to definitively say if it's 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 states that the device is a Transcutaneous Electrical Nerve Stimulator (TENS) used for pain relief. This is a therapeutic application, not a diagnostic one.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not involve the examination of such specimens.
The description focuses on the application of electrical stimulation to the body for pain management, which is a completely different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
Transcutaneous Electrical Nerve Stimulaton (TENS) devices are to be used for the symptomatic relief and management of chronic (long term) intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.
Product codes
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 (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 features the department's name in a circular arrangement around a stylized eagle. The eagle is depicted with three curved lines forming its body and wings, giving it a modern and abstract appearance. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 1998
Mr. Joe Fong American Imex 16520 Aston Street Irvine, California 92606
Re: K982221 Premier A-P Regulatory Class: II Product Code: GZJ Dated: June 4, 1998 Received: June 24, 1998
Dear Mr. Fonq:
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. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) 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 requlations.
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Page 2 - Mr. Joe Fong
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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other gener 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ___ K 9 8 2 2 2 |
PREMIER - A - P Device Name:
Indications For Use:
Transcutaneous Electrical Nerve Stimulaton (TENS) devices are to be used for the symptomatic relief and management of chronic (long term) intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982221
Prescription Use ... . . . . . . . . . . . . OR (Per 21 CFR 801-109) ---------------------------------------------------------------------------------------------------------------------------------------------------------
Over-The-Counter Use (1980-11-2012) Over-The
(Optional Format 1-2-96)