FDTENS 2010

K994266 · Fuji Dynamics Limited · GZJ · Jul 6, 2000 · Neurology

Device Facts

• Record ID: K994266
• Device Name: FDTENS 2010
• 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

FDTENS 2010 is a Transcutaneous Electrical Nerve Stimulation (TENS) unit; provides non-invasive, drug-free pain management. Device delivers electrical stimulation to nerves to treat chronic, acute, or post-operative pain. Operated by patients or clinicians in clinical or home settings. Output consists of electrical pulses applied via electrodes to the skin surface. Healthcare providers use the device to manage patient pain levels, potentially reducing reliance on pharmacological interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Transcutaneous Electrical Nerve Stimulation (TENS) unit; electrical stimulation delivery system; non-invasive; portable form factor.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

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: K994266

> Trade Name: FDTENS 2010 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 Ouality System Regulation (OS) 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 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,

Duane 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

K994266 FDTENS 2010

## 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

| | R. Vochner |
|--|----------------------------------|
| | Division Sign-Off |
| | ion of General Restorative Devic |
| | Number K994266 |

| Prescription Use | <div style="text-align:center;">X</div> | Or | Over-the-Counter-Use |
|----------------------|-----------------------------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |