MSB TENS ELECTRODES (DISPOSABLE)

K980229 · Msb , Ltd. · GXY · Feb 27, 1998 · Neurology

Device Facts

• Record ID: K980229
• Device Name: MSB TENS ELECTRODES (DISPOSABLE)
• Applicant: Msb , Ltd.
• Product Code: GXY · Neurology
• Decision Date: Feb 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Device Story

Device consists of disposable TENS electrodes. Used in clinical or home settings under prescription to deliver electrical stimulation for pain management. Electrodes interface with TENS units to transmit electrical current to patient skin. Benefit includes non-invasive pain relief. Operated by patients or healthcare providers.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable TENS electrodes. Class II device. Product code GXY.

Indications for Use

Indicated for use as TENS electrodes for prescription use.

Regulatory Classification

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.

Submission Summary (Full Text)

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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.

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## 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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K980229 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: પક્ષિ TENS Electroder Indications For Use: પિકિસ્ are 10 ರಿತ and

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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)