SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S.

K052182 · Shian Jia Meei Enterprise Co., Ltd. · GZJ · Nov 4, 2005 · Neurology

Device Facts

• Record ID: K052182
• Device Name: SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S.
• Applicant: Shian Jia Meei Enterprise Co., Ltd.
• Product Code: GZJ · Neurology
• Decision Date: Nov 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SHIAN JIA MEEI TWO Channel Digital T.E.N.S. is intended for symptomatic relief and management of chronic intractable pain.

Device Story

Two-channel digital Transcutaneous Electrical Nerve Stimulator (TENS) for symptomatic relief and management of chronic intractable pain; device delivers adjustable frequency, pulse width, and output current intensity via two sets of lead-wires and two pairs of cutaneous stimulation electrodes; powered by 9V battery; features large LCD panel; operated by user or clinician; provides electrical stimulation to nerves to manage pain; intended for chronic intractable pain management.

Clinical Evidence

Bench testing only. Device conforms to EN 60601-1, EN 60601-1-2, and FDA output waveform requirements.

Technological Characteristics

Two-channel digital TENS unit; 9V battery powered; adjustable frequency, pulse width, and output current intensity; large LCD interface; includes two lead-wire sets and two pairs of cutaneous electrodes; conforms to EN 60601-1 and EN 60601-1-2 standards.

Indications for Use

Indicated for symptomatic relief and management of chronic intractable pain in patients.

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

• TRIO 300 Multi-mode Electrical Stimulator (K990787)

Submission Summary (Full Text)

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## 510(K) SUN

K052182

NOV - 4

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

| 1. | Submitter's Name:<br>Address:<br>Tel:<br>Fax: | SHIAN JIA MEEI ENTERPRISE CO., LTD.<br>NO.5,HUA YUAN 2ND ST., PEI HUA VILLAG, KUANG MIAO HSIANG,<br>TAINAN HSIEN , TAIWAN · R.O.C.<br>886-6-5960879<br>886-6-5950259 |
|-------------------------|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact:<br>E-mail: | Mr. Michael Chen/General Manager<br>[e-mail] |
| 2. | Device Name<br>Trade Name: | SHIAN JIA MEEI TWO Channel Digital T.E.N.S. |
| | Common Name:<br>Classification name: | (Model no. TKL-008/168/268)<br>TENS unit<br>Transcutaneous Electrical Nerve Stimulator |
| 3. | Classification: | Class II |
| 4. | Predicate Device: | The predicate device is the TRIO 300 Multi-mode Electrical<br>Stimulator (k990787) marketed by ITO CO., LTD. |
| 5. | Device Description: | SHIAN JIA MEEI TWO Channel Digital T.E.N.S.( Transcuntaneus<br>Electrical Nerve Stimulator), is of independent two channels output ,<br>designed for symptomatic relief and management of chronic<br>intractable pain. It provides a combination of adjustable frequency ,<br>adjustable Pulse Width and adjustable output current intensity. |
| | | With large LCD panel. It is powered by 9V Battery. SHIAN JIA MEEI<br>TWO Channel Digital T.E.N.S. requires the use of two (2) set of<br>lead-wire and two (2) pairs of cutaneous stimulation electrodes. |
| | | Model No. description<br>TKL-008/ TKL-168/ TKL-268 is all the same except the Housing<br>printing artwork , model no. & destination. |
| 6. | Intended Use: | The SHIAN JIA MEEI TWO Channel Digital T.E.N.S. is intended for<br>symptomatic relief and management of chronic intractable pain. |
| 7. Performance Summary: | | In terms of operating specification, Safety & EMC requirements, the<br>device conforms to applicable standards included EN 60601-1, EN<br>60601-1-2 & related FDA Output waveform requirements. |

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## 8. Conclusions:

The SHIAN JIA MEEI TWO Channel Digital T.E.N.S. have the same intended use and similar nological characteristics as the TENS Mode of TRIO 300 Multi-mode Electrical Stimulator t the the the first of the formation of the formation of the formation of the formation of the formation of the formation of the formation of the formation of the formation o (k990787) marketed by ITO CO., LTD.. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the SHIAN JIA MEEI TWO Channel Digital T.E.N.S. is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines.

Public Health Service

NOV - 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jennifer Reich Representing Shian Jia Meei Enterprise Co., Ltd. 3892 South America West Trail Flagstaff, Arizona 86001

Re: K052182

Trade/Device Name: Shian Jia Meei Two-Channel Digital TENS. Model # TKL-008, TKL-168, and TKL-268 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: August 8, 2005 Received: August 10, 2005

Dear Ms. Reich:

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

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Page 2 - Jennifer Reich

applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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), nlease 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/industry/support/index.html.

Sincerely yours,

signature

Mark N. Melkerson Acting 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):__K 052182

Device Name: SHIAN JIA MEEI TWO Channel Digital T.E.N.S. (Model no. TKL-008/168/268) SHIAN JIA MEEI ENTERPRISE CO., LTD.

Indications For Use:

The SHIAN JIA MEEI TWO Channel Digital T.E.N.S. is intended for symptomatic relief and management of chronic intractable 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 (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

| 510(k) Number | K052182 |
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