(36 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description is for TENS electrodes, which are typically passive components.
Yes
The device is described as "TENS Electrodes" and its intended use is "TENS Electrodes are to be used". TENS devices are therapeutic in nature, used for pain relief.
No
Explanation: The intended use states "TENS Electrodes are to be used and". TENS (Transcutaneous Electrical Nerve Stimulation) devices are typically therapy devices for pain relief, not diagnostic devices.
No
The device description explicitly states "TENS Electrodes," which are hardware components used in TENS therapy. This indicates the device is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is "TENS Electrodes are to be used and". While incomplete, this strongly suggests a therapeutic or pain management application, not a diagnostic one performed in vitro (outside the body).
- Device Description: "TENS Electrodes" are components used in Transcutaneous Electrical Nerve Stimulation (TENS) therapy, which is a physical therapy modality.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, based on the available information, this device is intended for therapeutic use and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
TENS Electrodes are to be used for nerve stimulation.
Product codes
GXY
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
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is listed as 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.
FFB 2 7 1998
Mr. Peter Marks Quality Manager MSB Limited Ramsbury, Marlborough Wiltshire SN8 2RB United Kingdom
K980229 Re : MSB Tens Electrodes (Disposable) Regulatory Class: II Product Code: GXY Dated: January 14, 1998 Received: January 22, 1998
Dear Mr. Marks:
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 The general controls provisions of the Act 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 Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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.
1
Page 2 - Mr. Peter Marks
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA acocing 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) 594-4659. 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 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,
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
2
Page_ i ol
K980229 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: પક્ષિ TENS Electroder Indications For Use: પિકિસ્ are 10 ರಿತ and
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K980229
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)