EASY MED TN-28 C

K040253 · Easy Med Instrument Co., Ltd. · GZJ · Apr 8, 2004 · Neurology

Device Facts

• Record ID: K040253
• Device Name: EASY MED TN-28 C
• Applicant: Easy Med Instrument Co., Ltd.
• Product Code: GZJ · Neurology
• Decision Date: Apr 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

TN-28C T.E.N.S UNIT is commonly used to provide symptomatic pain relief for chronic, acute or post-operative pain.

Device Story

EasyMed TN-28C is a Transcutaneous Electrical Nerve Stimulator (TENS) providing symptomatic pain relief. Device delivers small electrical pulses through skin to nervous system; operates on gate control theory to block pain transmission. Input: user-adjusted settings (frequency, pulse width, intensity). Output: electrical stimulation via two channels. Powered by two 1.5V AA batteries. Features include five modes, timer, and open circuit detectors. Used by patients for pain management; clinical setting or home use. Healthcare providers use output to manage patient pain symptoms; device benefits patients by providing non-invasive pain relief.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Battery-powered (2x 1.5V AA) TENS unit. Two output channels. Features: adjustable frequency, pulse width, and intensity; 5 stimulation modes; timer; open circuit detectors; non-volatile memory. Form factor: handheld unit with large display.

Indications for Use

Indicated for symptomatic relief of chronic, acute, or post-operative 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

• FDTENS 2010 (K994266)

Submission Summary (Full Text)

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APR = 8 2004

K040253
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# 510(k) Summary

Submitter: EasyMed Instrument Co., Ltd Add: 2/F-3/F. No.2 BeiHai Da Rd LunJiao, Shunde, Guangdong, China Tel: [phone] 7727283 Fax: [phone]

#### Submitted Device:

Trade name: EasyMed TN-28C TENS UNIT Common name: Transcutaneous Electrical Nerve Stimulator (T.E.N.S)

#### ldentification of the legally marketed device

The legally marketed device which EasyMed is claiming equivalence: 510(k) No: K994266 Device name: FDTENS 2010 Manufacturer: Fuji Dynamics Ltd

The TN-28C TENS Unit is SE to the FDTENS 2010, their circuits design are based on the same principle; Both of them use two 1.5V AA batteries and have two output channels; their output electrical parameters, frequency, pulse width, and intensity, etc., are very similar substantially

#### Description of the submitted device

T.E.N.S. stands for Transcutaneous Electrical Nerve Stimulation. This T.E.N.S. system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.

We do not feel pain until a coded message travels to the brain where it is decoded, analyzed and responded to. The pain message travels from the affected area along small nerve fibers leading into the spinal cord. Here the message is relayed to different nerves that travel up the spinal cord to the brain.

The kind provided to you by your personal Transcutaneous Electrical Nerve Stimulator, TN-28C T.E.N.S. Unit consists of sending small electrical pulses through the skin to the body's nervous system. According to the " gate " theory for pain control, the stimulation of large nerve fibers may result in the blocking of pain transmission.

#### Features:

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- Innovative design
- Large display
- Adjustable frequency
- 5 different modes
- Timer option
- Adjustable pulse width
- Open circuit detectors
- Non-volatile

### The intended use of the device:

TN-28C T.E.N.S UNIT is commonly used to provide symptomatic pain relief for chronic, acute or post-operative pain.

K040253

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

Public Health Service

APR = 8 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EasyMed Instrument Co., Ltd. c/o Mr. Stefan Preiss TÜV Product Servicc 1775 Old Highway 8 New Brighton, Minnesota 55112-1891

Re: K040253

Trade/Device Name: EasyMed TN-28C T.E.N.S. Unit Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: March 22, 2004 Received: March 24, 2004

Dear Mr. Preiss:

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 cither 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 complics 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. Stefan Preiss

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,

sincerely yours,

Mark H. Wilkerson

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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## Indications for Use

510(k) Number (if known): _K040253

Device Name: EasyMed TN-28C T.E.N.S. UNIT

Indications For Use:

T.E.N.S. stands for Transcutaneous Electrical Nerve Stimulation. This T.E.N.S. system 1 .E.N.O. Stands for Transoutanoous Ellef for chronic, acute or post operative 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)

for

Mark N Mellers

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

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510(k) Number. K040253