MEDISANA DIGITAL TENS

K994265 · Fuji Dynamics Limited · GZJ · Jul 6, 2000 · Neurology

Device Facts

• Record ID: K994265
• Device Name: MEDISANA DIGITAL TENS
• Applicant: Fuji Dynamics Limited
• Product Code: GZJ · Neurology
• Decision Date: Jul 6, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Medisana Digital TENS is a non-invasive, drug-free pain management device. It delivers transcutaneous electrical nerve stimulation to treat chronic, acute, or post-operative pain. The device is intended for use by patients for pain relief. It functions as a portable electrical stimulator; specific input/output mechanisms and clinical decision-making workflows are not detailed in the provided documentation.

Clinical Evidence

No clinical data provided. Determination of substantial equivalence based on 510(k) notification review.

Technological Characteristics

Digital TENS unit; non-invasive electrical stimulation for pain management. Specific materials, dimensions, and software architecture are not described.

Indications for Use

Indicated for the treatment of chronic, acute, or post-operative pain in patients requiring non-invasive, drug-free pain management.

Regulatory Classification

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.

Submission Summary (Full Text)

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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: K994265 Trade Name: Medisana Digital TENS 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 Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 [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.

iane 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

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510(k) Number Device Name

## K994265 MEDISANA DIGITAL TENS

## 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({{ (Division Sign-Off) Division Sign-Off)
Sivision of General Restorative Devices Prescription Use Over-the-Counter-Use Or (Per 21 CFR 801.109) (Optional Format 1-2-96)