ES-160

K051020 · Lhasa Oms, Inc. · GZJ · Feb 24, 2006 · Neurology

Device Facts

• Record ID: K051020
• Device Name: ES-160
• Applicant: Lhasa Oms, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Feb 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ES-160 is intended for use in pain relief. It can be used by a physician on his patients. This is a prescription device and should be used under continued medical supervision. The intended use of the Pointer F-3 is identical. It does not have curative value, but relieves pain symptoms.

Device Story

Battery-powered portable TENS device; includes remote grounding pole and handheld locator/stimulator probe. Operates by making skin contact with grounding pole; probe tip identifies low-burn-risk skin areas via auditory signals and meter readings. Stimulation mode generates low-level electrical pulses (square waveform) via button press. Used by physicians in clinical settings for symptomatic pain relief. Does not provide curative treatment; suppresses pain signals. Potential for unpleasant sensation in some patients.

Clinical Evidence

Bench testing only. Compliance with international standards including IEC 60601-1, IEC 60601-2-10, and various EN electromagnetic compatibility and safety standards.

Technological Characteristics

Battery-powered (four 1.5V batteries); handheld probe and grounding pole; DC current for location; square waveform pulses for stimulation; conforms to IEC 60601-1, IEC 60601-2-10, and EN 50081/55011/55014/55022/60601-1-2/61326/60555/61000 series standards.

Indications for Use

Indicated for the treatment of chronic, acute, and post-operative pain. Contraindicated for transcerebral use, carotid sinus area, pregnancy, patients with demand cardiac pacemakers, or patients with suspected heart disease without precautions.

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

• Pointer F-3 (K904388)

Submission Summary (Full Text)

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K 05/020

### FEB 2 4 2006

F-1

### F. 510(k) Summary

Submitters information: OMS Medical Supplies, Inc. 230 Libbey Parkway Weymouth, MA 02189

Contact Person: Mark W. Sheehan Telephone: [phone] ext. 20 Fax: [phone]

Date Summary Prepared: April 15, 2005

Device name:

| Proprietary name: | ES-160 |
|-----------------------|---------------------------------------------------------------------------|
| Common or usual name: | Portable transcutaneous electrical nerve<br>stimulator (TENS) |
| Classification name: | Transcutaneous electrical nerve<br>stimulator, Class II, 21 CFR 882.5890. |

Legally marketed device for substantial equivalence comparison: Pointer F-3, K904388

## Description of the device:

The device consists of a battery powered portable instrument with a remote grounding pole and a hand held locator/stimulator probe. Six output channels are grounding polo and time. The grounding pole is held in order to make contact with the skin. Moving the probe tip across the skin identifies places where the risk of skin burns is low. Auditory signals as well as a meter reading indicate when this has occurred. Holding the probe in place and pushing the stimulation button generates low level electrical pulses as long as the button is pressed.

#### Intended use of the device:

The ES-160 is intended for use in pain relief. It can be used by a physician on his patients. This is a prescription device and should be used under continued medical supervision. The intended use of the Pointer F-3 is identical. It does not have curative value, but relieves pain symptoms.

The ES-160 cannot be used transcerebrally, in the carotid sinus area or during pregnancy. Patients suspected of having heart disease should consider adequate precautionary measures prior to administration. Severe spasm of the laryngeal and pharyngeal muscles may occur when an electrode is placed across the neck or mouth. This may be enough to close off the airway. Stimulation will inhibit the output of some demand cardiac pacemakers and therefore, is not recommended for patients with this type of pacemaker.

Electrical nerve stimulation is a symptomatic treatment, and as such may suppress the progress of pain which would otherwise serve as a protective

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influence on the outcome of a disease process. The potential for physical and/or innuchoe on the outsome on on nerve stimulation as a means of relieving pain has not been determined.

It has been noted that some patients find the sensation of electrical stimulation extremely unpleasant and should probably be excluded from further use of the stimulator.

### Technological Characteristics:

Both devices use four 1.5 volt batteries. Both devices have a location mode and a stimulation mode. The location output of both devices is DC current. During stimulation the electrical output for both devices is square waveform pulses. Details of electrical output are different but new safety concerns are not raised by the differences. Controls on each device assess skin burn risk and regulate stimulation intensity. Electrode 510(k) number: K946230.

Performance Data: Below is the list of the applied standards: EN 50081-1/1991 EN 50081-3/1993 EN 55011/1998 A1/ 1999 EN 55014-1/ 1993 A2/ 1999 EN 55022/ 1998 EN 60601-1-2/ 1993 EN 61326/ 1997 A1/ 1998 EN 60555-2/ 1987 EN 60555-3/ A1 1992 EN 6100-3-2/A13 1997 EN 61000-3-3/ 1995 IEC 60601-1 IEC 60601-2-10

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 2006

Mr. Mark W. Sheehan OMS Medical Supplies, Inc. 230 Libbey Parkway Weymouth, Massachusetts 02189

Re: K051020

Trade Name: ES-160 TENS Unit Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: II Product Code: GZJ Dated: February 6, 2006 Received: February 8, 2006

Dear Mr. Sheehan:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your bocurent of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use suited in the encreate) 75 ttg enactment date of the Medical Device Amendments, or to conninered prior to May 20, 1978, the exacted with the provisions of the Federal Food, Drug, de rices that have been reciasined require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mererore, maines of the Act include requirements for annual registration, listing of genoral controls provisiveing 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 If your device is elaboried (soval controls. Existing major regulations affecting your device can may or saleyee to back added of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the over cements 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 that 1151 has Intact a and regulations administered by other Federal agencies. You must of any I cacal statutes und regaintents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Mark W. Sheehan

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin marketing of substantial equivalence of your device to a legal!y premarket nothication. The PDA midning of backanda vip.
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 If you desire specific advice for your do 7.0 % on a more the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain " Misbranding by reference to premance hourfeasons
other general information on your responsibilities under the Act from the 1990s 628.000 other general informational and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Consulter Prosposition of the more of the new onlyindex.html.

Sincerely yours,

Hecho Lenero

for

Mark N. Melkerson, M.S. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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# ltem 2. Indications for Use

510(k) Number (if known): K051020, Device Name: ES-160

Indications for Use:

The ES-160 is designed to be used in the treatment of chronic, acute and post-operative pain.

Prescription Use × AND/OR 21 CFR 810 Subpart D) (21 CFR 801 Subpart C)

Over-The-Counter Use (Part

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE

tion (ODE)

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(Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________