GEMORE TRUE SINE INTERFERENTIAL STIMULATOR

K122944 · Gemore Technology Co, Ltd. · LIH · Dec 21, 2012 · Neurology

Device Facts

• Record ID: K122944
• Device Name: GEMORE TRUE SINE INTERFERENTIAL STIMULATOR
• Applicant: Gemore Technology Co, Ltd.
• Product Code: LIH · Neurology
• Decision Date: Dec 21, 2012
• Decision: SESE
• Submission Type: Special
• 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

Gemore IF series (Models GM3A00IF, GM3A10IF, GM3A20IF, GM3A50IF) are interferential stimulators generating true-sine electrical pulses. Device delivers current to patient skin/nerves via cables and electrodes. Used for symptomatic relief and management of chronic intractable pain. Operation involves analog interface with 4 modes and maximum intensity adjustment up to 70mA. Device is intended for prescription use.

Clinical Evidence

Bench testing only. Compliance with voluntary standards (ANSI/AAMI NS4-1985, IEC 60601-1, IEC 60601-1-2) and software verification per FDA guidance.

Technological Characteristics

True-sine interferential stimulator; analog operation; 4 modes; max intensity 70mA. Complies with ANSI/AAMI NS4-1985, IEC 60601-1, and IEC 60601-1-2. Electrical stimulation via skin electrodes.

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

• Gemore IF TENS/Model: GM322IF (K032719)

Submission Summary (Full Text)

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510(K) Summarv

DEC 2 1 2012

This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 on August 30, 2012.

The assigned 510(k) number is: _ k122944

1. Submitter 's Identifications:

| Company Name : | GEMORE TECHNOLOGY CO., LTD. |
|------------------|-----------------------------------------------------------------------------|
| Contact person: | Boden S.P. Lai |
| Address : | 11FL., NO. 29-5, Sec. 2, Chung Cheng E. RD., Tan Shui, Taipei Hsien, Taiwan |
| TEL No. : | 886-2-8809-1799 |
| Fax No. : | 886-2-8809-1781 |
| E-mail address : | [e-mail] |

- 2. Name of the Device:
Trade/Device Name: Gemore IF True Sine Interferential Stimulator Model GM3A001F/GM3A10IF/GM3A20IF/GM3A50IF Regulation Number: Unclassified Regulation Name: Interferential Stimulator Requlatory Class: II Product Code: LIH

- 3. Information of the 510(k) Cleared Device (Predicate Device):
Gemore IF TENS/Model: GM322IF(K032719).

### 4. Dev ice Description:

The Gemore IF series True sine interferential stimulator / Model: GM3A00IF/GM3A10IF/ GM3A20IF/GM3A50IF are the device which generates the small true-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.

- 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. Subst antial Equivalence Comparison

The Gemore IF series True sine interferential stimulator / Model: GM3A00IF/GM3A10IF/ GM3A20IF/GM3A501F have output characteristics and controls that are identical to those of the predicate device. The new devices were modified different from the predicate device with the following different features:

- 1> The new device housing was designed and constructed for each model.
- 2> The firmware, software and operation interface were change so as to change the operation type from digital to analog.
- 3.> The maximum intensity adjustment range was changed from 60mA to 70 mA.
- 4> The operation modes was reduced from 9 modes into 4 modes,

## 7. 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 IEC 60601-1, and IEC 60601-1-2 requirement.

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

#### 8. Conclusions_

The Gemore IF true sine interferential stimulator. model GM3A00IF/GM3A10IF/GM3A20IF /GM3A50IF, has the same intended use and technological characteristics as the cleared device of GM322IF(K032719). Moreover, 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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Public Health Service

December 21, 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Gemore Technology Company, Ltd. % Mr. Boden S. P. Lai General Manager 11 Fl, No. 29-5, Sec 2 Chung Cheng E. Rd Tan Shui, Taipei Hsien China (Taiwan) 25 1

Re: K122944

Trade/Device Name: Gemore IF series True sine interferential stimulator/Model GM3A00IF/GM3A10IF/GM3A20IF/GM3A50IF

Regulation Number: Unclassified Regulation Name: Interferential Stimulator Regulatory Class: Class II Product Code: LIH Dated: September 21, 2012 Received: September 24, 2012

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Mr. Lai

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Victor Krauthamer -S

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_ 1 _of_

#### 次1229444 510(k) Number (if known):_

# Device Name: Gemore IF series True sine interferential stimulator Model: GM3A00IF/GM3A10IF/GM3A20IF/GM3A50IF

## 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)

Prescription Use V OR

(Division Sign-Off)
Division of Neurological and Physical

Division of Neurological and Physical Medicine Devices 510(k) Number

Over-The-Counter Use

(Optional Format 1-2-96)