GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING)

K032719 · Gemore Technology Co, Ltd. · LIH · Dec 10, 2003 · Neurology

Device Facts

• Record ID: K032719
• Device Name: GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING)
• Applicant: Gemore Technology Co, Ltd.
• Product Code: LIH · Neurology
• Decision Date: Dec 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.

Device Story

The GM3X2IF is an interferential stimulator that generates small real-sine electrical current pulses. The device delivers these pulses to the patient's skin and underlying nerves via cables and electrodes. The stimulation is intended to provide symptomatic relief and management of chronic intractable pain. It is designed for use by patients or clinicians to manage pain conditions. The device operates by applying electrical current to the body, which is a standard method for pain modulation.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including compliance with voluntary electrical safety and performance standards (ANSI/AAMI NS4-1985, EN 60601-1, EN 60601-1-1, EN 60601-1-2) and software verification.

Technological Characteristics

Interferential stimulator generating real-sine electrical current pulses. Compliance with ANSI/AAMI NS4-1985, EN 60601-1, EN 60601-1-1, and EN 60601-1-2. Device includes housing variations (model GM3X2IF, where X=0-5).

Indications for Use

Indicated for symptomatic relief and management of chronic intractable pain in patients requiring interferential or TENS therapy.

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

• IF-400 (k930535)
• IF-4000 (k952683)

Submission Summary (Full Text)

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GENIURE TEUHNULUGY UU., LI U.

### 510(K) SUMMARY

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This summary of 510(k) 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:

DEC 1 0 2003

- Submitter's Identifications: 1. GEMORE TECHNOLOGY CO., LTD. 11FL., NO. 29-5, Sec. 2, Chung Cheng E. RD., Tan Shui, Taipei Hsien, Taiwan
Contact: Boden S.P. Lai General Manager

Date of Summary Preparation: July 25, 2003.

- 2. Name of the Device:
GEM IF TENS, True sine interferential stimulator / Model: GM3X2IF, where X is the parameter for different housing.

- 3. Information of the 510(k) Cleared Device (Predicate Device):
IF-400 (k930535) and IF-4000 (k952683).

### 4. Device Description:

The GM3X2IF is the device which generates the small real-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved.

### 5. Intended Use:

The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.

In addition, the standard format for the statement of indications and contraindication for use are provided hereafter.

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# 6. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:

Compliance to applicable voluntary standards includes ANSI/AAMI, NS4-1985, as well as EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement.

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

## 7. Conclusions

The true sine interferential stimulator, model GM3X2IF, has the same intended use and technological characteristics as the cleared device of IF-400 (k930536), and IF-4000 (k952683). to relover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device.

In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 2003

Mr. Boden S.P. Lai General Manager Gemore Technology Co., Ltd. 11FL., No. 29-5, Scc. 2, Chung Cheng E. RD., Tan Shui, Taipei Hsien, Taiwan

Rc: K032719

Trade/Device Name: GM3 Series IF TENS Model GM3X2IF Regulation Number: Unclassified Generic Device Type: Interferential current therapy stimulator Regulatory Class: Unclassified Product Code: LIH Dated: July 26, 2003 Received: September 12, 2003

Dear Mr. Lai:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (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 advised that FDA's issuance of a substantial equivalence determination does 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 agencics. 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Boden S.P. Lai

This letter will allow you to begin marketing your device as described in your Section 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). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97).

You may obtain other general information on your responsibilities under the Act 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 Millenn

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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#### 6032719 510(k) Number (if known):

Device Name: GEM IF TENS, True sine interferential stimulator / Model: GM3X2IF, where X is the parameter for different housing with range from 0 to 5.

### Indications For Use:

The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Gener
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^) Number K032719

Prescription Use OR Over-The-Counter Use

(Optional Format 1-2-96)