GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)

K032994 · Gemore Technology Co, Ltd. · GZJ · Dec 16, 2003 · Neurology

Device Facts

• Record ID: K032994
• Device Name: GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)
• Applicant: Gemore Technology Co, Ltd.
• Product Code: GZJ · Neurology
• Decision Date: Dec 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

GM3X3HV is a high voltage transcutaneous electrical nerve stimulator (TENS). Device generates twin high voltage electrical pulses delivered to patient skin via cables and electrodes. Stimulation targets underlying nerves to provide relief for chronic and acute pain. Operated by patient or clinician in clinical or home settings. Output parameters are controlled by the device to manage pain symptoms.

Clinical Evidence

Bench testing only. Compliance with ANSI/AAMI NS4-1985, EN 60601-1, EN 60601-1-1, and EN 60601-1-2 standards. Software verification performed per FDA guidance.

Technological Characteristics

High voltage TENS device; generates twin high voltage electrical pulses. Compliance with ANSI/AAMI NS4-1985, EN 60601-1, EN 60601-1-1, and EN 60601-1-2. Includes software-controlled parameters. Housing variations (GM3X3HV where X=0-5).

Indications for Use

Indicated for symptomatic relief and management of chronic intractable 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

• PGS123 (K946299)

Submission Summary (Full Text)

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### 510(K) SUMMARY

K032994

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 6 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: September 15, 2003.

#### 2. Name of the Device:

GEM-HV TENS (Also known as GEM-PGS TENS), High Voltage TENS Device / Model; GM3X3HV, where X is the parameter for different housing.

- 3. Information of the 510(k) Cleared Device (Predicate Device):
PGS123 (k946299).

## 4. Device Description:

The GM3X3HV is the device which generates twin high voltage 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 high voltage TENS device 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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#### 510(K) SUMMARY

# 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 high voltage TENS device, model GM3X3HV, has the same intended use and i ne filgh voltage TENS donos, model end device of Skylark PGS123 (k946299). Moreover, technological characteried as the circular this submission demonstrate that the difference in vellifed 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 6 2003

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

Re: K032994

Trade/Device Name: GM3 Series HV TENS Model GM3X3HV Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: September 23, 2003 Received: September 29, 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 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 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 N Millasson

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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GEMORE TECHNOLOGY CO., LTD.

510(K) SUMMARY

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510(k) Number (if known):

Device Name: GEM-HV TENS (Also known as GEM-PGS TENS), High Voltage TENS Device / Model: GM3X3HV, where X is the parameter for different housing with range from 0 to 5.

#### Indications For Use:

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

Prescription Use _ V (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 (ODE)

Marli N Milkerson

11103-6330 00081 Wision of Coneral, Restorative and Neurological Devices

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