(36 days)
TENS Electrodes are to be used for nerve stimulation.
TENS Electrodes
The provided text describes a 510(k) premarket notification for MSB Tens Electrodes and the FDA's determination of substantial equivalence. However, it does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt regarding a study that proves the device meets acceptance criteria.
The document is a regulatory letter from the FDA to MSB Limited, confirming that their Tens Electrodes are substantially equivalent to devices marketed prior to May 28, 1976. This letter signifies a regulatory clearance to market the device, but it does not detail the testing or studies that led to this determination. Such studies would typically be part of the 510(k) submission, but their results are not included in this particular document.
Therefore, I cannot provide the requested information based on the given text.
{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)
§ 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).