L-TENS

K041164 · Fuji Dynamics Limited · GZJ · May 20, 2004 · Neurology

Device Facts

• Record ID: K041164
• Device Name: L-TENS
• Applicant: Fuji Dynamics Limited
• Product Code: GZJ · Neurology
• Decision Date: May 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Device Story

Handheld, battery-powered TENS unit; generates electrical pulses transmitted via skin electrodes to peripheral nerves to block pain signals. Features one output channel, four preset programs, and 14-step adjustable output intensity. Includes open-circuit detection to verify electrode continuity and prevent output increment without load. Operated by patient or clinician for pain management. Output displayed on LCD. Benefits include non-invasive pain relief.

Clinical Evidence

No clinical data; bench testing only. Compliance with ANSVAAMI NS4-1986, EN 60601-1, EN 60601-1-1, and EN 60601-1-2 standards confirmed. Software verification performed per FDA guidance.

Technological Characteristics

Battery-powered TENS stimulator; handheld form factor. Features one output channel, LCD display, and 14-step intensity adjustment. Includes open-circuit detection circuitry. Uses shrouded patient cable connectors per FDA performance standards. Compliance with EN 60601-1 series and ANSVAAMI NS4-1986.

Indications for Use

Indicated for symptomatic relief and management of chronic intractable pain, and as adjunctive treatment for post-surgical and post-traumatic acute pain.

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.

Predicate Devices

• FDTENS 2010 (K994266)

Submission Summary (Full Text)

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## MAY 2 0 2004

## 10 510(k) Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

#### 10.1 Submitter's Identification

Fuji Dynamics Ltd. Unit 1-3, 23/F., Laws Commercial Plaza, 788 Cheung Sha Wan Road, Kowloon, Hong Kong Tel: [phone] Fax: [phone]

Contact Person: Anthony Ah Yin, Shum April 29th 2004 Date Prepared:

#### 10.2 Name of Device:

| Proprietary Name: | L-TENS |
|------------------------|-------------------------------------------------------------------------|
| Common or Usual Name: | TENS unit |
| Classification Name: | Stimulator, Nerve, Transcutaneous, for Pain Relief<br>(21 CFR 882.5890) |
| Device Classification: | Class II |

#### 10.3 Predicate Device Information:

The L-TENS is equivalent to the FDTENS 2010 (K994266).

#### 10.4 Device Description:

The L-TENS is a handheld battery powered TENS device, which is used for pain relief. The device would generate electrical pulses and transmit it to the electrodes, which are attached to the patient's skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.

L-TENS has one output channel and four preset programs. The program mode is displayed on a LCD. The user can adjust the output intensity by 14 steps.

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#### 10.5 Intended Use:

TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

#### 10.6 Technological Comparison to Predicate Device:

The L-TENS has basic technological characteristics that are substantially equivalent to the predicate device. Both devices are battery powered and have adjustable output amplitudes. On the contrary, the legally marketed predicate device has dual channels, while L-TENS is a 1-channel device. The only significant technological difference between the two devices is that L-TENS possesses an open-circuit detection feature. It means that L-TENS could check the continuity between the output terminals, and avoid increment of output in the absence of load.

All units use "shrouded patient cable connectors" to comply with the FDA's Final Rule "Mcdical Devices: Establishment of Performance Standards for Electrode Lead Wires and Patient Cables."

#### 10.7 Non-clinical Testing:

Compliance to applicable voluntary standards includes ANSVAAMI NS4-1986, as well as EN 60601-1, EN 60601-1-1 and EN 60601-1-2 requirements.

In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance.

#### 10.8 Clinical Testing

Not Applicable as there are no new or innovative aspects that have been introduced.

#### 10.9 Conclusions:

The L-TENS has the same intended use and similar technical characteristics as the FDTENS 2010 (K994266).

The information supplied in this 510(k) illustrates that the device do not pose any new questions of safety and effectiveness. Therefore, the L-TENS is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### MAY 2 0 2004

Anthony Ah Yin, Shum R & D Department Unit 1-3, Laws Commercial Plaza 788 Cheung Sha Wan Road Hong Kong. China

Re: K041164

Trade/Device Name: L-TENS Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: GZJ Dated: April 30, 2004 Received: May 3, 2004

Dear Mr. Shum:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be adviscd that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Anthony Ah Yin, Shum

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo lotest 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilitics under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark A. Milburn

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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# Indications for Use

510(k) Number (if known):

Device Name: L-TENS

Indications For Use:

The L-TENS is used for the symptomatic rclief and management of chronic intractable pain The 1.- I ENS is used in the symptomation of post-surgical and post-surgical and post-traumatic pain.

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation
*for* Mark
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

| 510(k) Number | K091169 |
|---------------|---------|
|---------------|---------|

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