TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS

K991397 · Sein Electronics Co., Ltd. · GZJ · Feb 11, 2000 · Neurology

Device Facts

• Record ID: K991397
• Device Name: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS
• Applicant: Sein Electronics Co., Ltd.
• Product Code: GZJ · Neurology
• Decision Date: Feb 11, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

the SEIN SE-30 TENS device is indicated for the symptomatic relief and management of chronic (long-term) intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Device Story

SE-30 TENS is a transcutaneous electrical nerve stimulator; delivers electrical pulses via adhesive gel pads to skin surface. Device operates on two 1.5V AAA batteries; generates asymmetric bi-phasic rectangular pulses with zero net DC. Features four programmed treatment modes (modulation and burst patterns); pulse rates 1-200 pps; pulse widths 105-450 µs. Used by patients or clinicians for pain management; provides symptomatic relief of chronic intractable pain or adjunctive treatment for post-surgical/post-traumatic pain. Output parameters controlled by internal circuitry; device automatically discriminates polarity. Healthcare providers use output to manage patient pain levels; device provides non-pharmacological pain relief option.

Clinical Evidence

Bench testing only. Device tested for compliance with ANSI/AAMI NS4-1985 standards for transcutaneous electrical nerve stimulators.

Technological Characteristics

Asymmetric bi-phasic rectangular pulse waveform; zero net DC. Powered by two 1.5V AAA batteries. Dimensions: 70x79x17 mm; weight: 80g. Adhesive gel pad electrodes. Pulse rate: 1-200 pps; pulse width: 105-450 µs. Compliance: ANSI/AAMI NS4-1985.

Indications for Use

Indicated for patients requiring symptomatic relief and management of chronic intractable pain or 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

• Micro TENS Plus (Graham-Field, Inc.)

Submission Summary (Full Text)

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出事

K99 139 7
11/3

## ELECTRONICS CO. , LTD. SEIN

133-3 PYUNGCHON-DONG, DONGAN-GU, ANYANG-SHI, KYUNGKI-DO, KOREA TEL: ANYANG [phone], FAX:[phone]

## 510(k) SUMMARY

"This 510(k) summary of Safety and Effectiveness information is being summitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. "

The assigned 510(k) number is _ __________ a market met service and the sense the sense many of

Applicant SEIN Electronics Co.,Ltd. 133-3 Pyungchon-Dong, Dongan-Gu, Anyang-Shi, Kyungki-Do, Korea Tel:Anyang(0343)421-0389 Fax:[phone]

Mr. S. H. Hwang, President Contact Forecare, Inc. 1540 Barclay Boulevard Buffalo Grove, IL 60089 Tel: [phone] Fax: [phone]

Date March 16, 1999

Name of Device

Proprietary Name : SE-30 TENS Common or Usual Name : Transcutaneous Electrical Nerve Stimulator Classification Name : Stimulator, Nerve, Transcutaneous (Pain Relief)

The SEIN SE-30 TENS device is equivalent to the Graham-Field, Inc. Micro TENS Plus transcutaneous electrical nerve stimulator.

Each product is used for the symptomatic relief of and management of long term intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain.

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A comparison of general specifications between the two devices is as follows:

| | SEIN | GRAHAM-FIELD |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| ITEM | SE-30 TENS | Micro TENS Plus |
| Output Channels | One output channel | Two with individual controls |
| Pulse Shape | Asymmetric bi-phasic &<br>phasic rectangular shape with<br>zero net direct current | Asymmetric bi-phasic &<br>phasic rectangular shape with<br>zero net direct current |
| Pulse Width | 105-450 us programmed insert<br>protected circuit | 50-200 us variable |
| Pulse Rate | 1-200 pulse/sec programmed | 1-200 pulse/sec variable |
| Power Source | two alkaline AAA batteries<br>1.5 volt | 9 volt alkaline or NiCd bat.<br>(rechargeable option) |
| Maximum Voltage | | |
| Load | 26 V | 17 V |
| 200 ohm | 40 V | 32 V |
| 500 ohm | 52 V | 45 V |
| 1 Kohm | 90 V | 90 V |
| open | | |
| Maximum Output | | |
| charge/pulse<br>(500 ohm load for safety) | 58.5 uc/pulse | 14.3 uc/pulse |
| Maximum Output | | |
| average current<br>(500 ohm load for safety) | 3.375 mA | 2.3 mA |
| Size | 70(W) x 79(H) x 17(D) mm | 90(W) x 59(H) x 25(D) mm |
| Weight | 80 grams | 142 grams |
| Recharge Battery Option | N | Y |
| Battery Check | N | Y |
| Water Use Option | N | Y |
| Discriminate Polality | Automatically Change | Required |
| Gel Pad | Adhesive Type | Adhesive Type |
| Treatment | 15 min. (no daily limit)<br>Mode 1: [Modulation]<br>1. Pulse Rate : 1-100 pps<br>2. Pulse Width: 220-450 usec | 15, 30min. (no daily limit)<br>Constant Mode<br>1. Pulse Rate : 1-200 pps<br>2. Pulse Width: 50-200 usec |
| MODES AVAILABLE | Mode 2... [Burst]<br>1. Pulse Rate:<br>16 pulse/burst. 4b/sec<br>16 pulse/burst. 7b/sec<br>63-125 pps<br>2. Pulse Width : 105-450 usec | Burst Mode<br>1. Pulse Rate:<br>10 pulse/burst. 2b/sec<br>2. Pulse Width: 50-200 usec |
| | Mode 3... [Modulation]<br>1. Pulse Rate : 1-5 pps<br>2. Pulse Width : 220 usec | Modulation Mode<br>1. Pulse Rate : 1-200 pps<br>2. Pulse Width: 50-200 usec |
| | Mode 4... [Burst]<br>1. Pulse Rate:<br>220 pulse/burst, 1b/sec<br>90 pulse/burst. 1b/sec<br>2. Pulse Width: 220-450 usec | |

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The SE-30 TENS device also was tested according to the standards of ANSI/AAMI NS4-1985 and was found to meet the requirements.

Mar. 16. 1999

Date

Tung

Tae Young Choi, President

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized symbol consisting of three abstract human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, bold line style.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2000

Mr. S. H. Hwang President SEIN Electronics Company, Ltd. C/O Forecare, Inc. 1540 Barclay Boulevard Buffalo Grove, Illinois 60089

Re: K991397

> Trade Name: Transcutaneous Electrical Nerve Stimulator SE-30 TENS Regulatory Class: II Product Code: GZJ Dated: November 8, 1999 Received: November 18, 1999

Dear Mr. Hwang:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed

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Page 2 – Mr. S. H. Hwang

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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Mark N. Melkerson

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K991397

Device Name: Transcutaneous Electrical Nerve Stimulator - SE-30 TENS

Indications For Use: the SEIN SE-30 TENS device is indicated for the symptomatic relief and management of chronic (long-term) intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

## PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use

Prescription Use × (Per 21 CFR801.109)

OR

(Optional Format 1-2-96)