E-STIM II

K050435 · Lhasa Oms, Inc. · GZJ · Sep 6, 2005 · Neurology

Device Facts

• Record ID: K050435
• Device Name: E-STIM II
• Applicant: Lhasa Oms, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Sep 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The E-Stim II is intended for use in the symptomatic relief of chronic intractable pain, post traumatic acute pain, and post surgical pain. It is designed for use by a therapist. This is a prescription device and should be used under continued medical supervision. The intended use of the Well-Tens is identical. It does not have curative value, but relieves pain symptoms.

Device Story

E-Stim II is a portable, battery-powered (9V) transcutaneous electrical nerve stimulator (TENS). Device features dual-channel outputs connected to lead wires and electrodes. Operated by a therapist in a clinical setting under medical supervision. User adjusts intensity and frequency controls to deliver square waveform pulses to the patient. Output provides symptomatic pain relief for chronic intractable, post-traumatic, or post-surgical pain. Device does not provide curative treatment. Safety precautions include avoiding neck/mouth placement to prevent airway obstruction and avoiding use in patients with demand cardiac pacemakers.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and adherence to recognized safety standards (ISO 14971, EN ISO 10993, EN 60601-1, EN 60601-1-2, EN 980).

Technological Characteristics

Battery-powered (9V) TENS device; dual-channel output; square waveform pulses. Materials: electrodes and lead wires identical to predicate. Standards: ISO 14971:2000, EN ISO 10993 (parts 1, 5, 10), EN/IEC 60601-1 (1988/1990/1993/1995/1996), EN/IEC 60601-1-2:2001, EN 980:2003. Manual controls for intensity and frequency.

Indications for Use

Indicated for symptomatic relief of chronic intractable pain, post-traumatic acute pain, and post-surgical pain. Contraindicated for transcerebral use, carotid sinus area, pregnancy, and patients with demand cardiac pacemakers. Not for patients who find electrical stimulation sensation unpleasant.

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

• Well-TENS (K002874)

Submission Summary (Full Text)

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## F. 510(k) Summary

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

Contact Person: Mark W. Sheehan

Telephone: [phone] ext. 20 Fax: [phone]

Date Summary Prepared: June 10, 2005

Device name:

| Proprietary name: | E-Stim II |
|-----------------------|----------------------------------------|
| Common or usual name: | Portable transcutaneous electrical |
| | nerve stimulator (TENS) |
| Classification name: | Transcutaneous electrical nerve |
| | stimulator, Class II, 21 CFR 882.5890. |

Legally marketed device for substantial equivalence comparison: Well- TENS, K002874

Description of the device:

The device consists of a battery powered portable instrument with dual channel outputs connected to lead wires and electrodes. Setting the output switch and the intensity controls will deliver the desired stimulation. Adjusting the frequency control will change the stimulation as well. Treatment continues as long as the intensity control dial switch is on.

## Intended use of the device:

The E-Stim II is intended for use in the symptomatic relief of chronic intractable pain, post traumatic acute pain, and post surgical pain. It is designed for use by a therapist. This is a prescription device and should be used under continued medical supervision. The intended use of the Well-Tens is identical. It does not have curative value, but relieves pain symptoms.

The E-Stim II 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 the 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 influence on the outcome of a disease process. The potential for physical

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and/or psychological dependence upon 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 one 9 volt battery. 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 regulate stimulation intensity and frequency. Material composition of the electrodes and the lead wires is identical.

Standards: The E-Stim II has been designed and tested to conform to the following standards: ISO 14971:2000 EN ISO 10993.1:1997/EN ISO 10993.5:1999/ EN ISO 10993.10.2002 EN 60601-1:1990+A1:1993+A2:1995+A13:1996/ IEC 60601-1:1988+A1:1991+A2:1995 EN 60601-1-2:2001/IEC 60601-1-2:2001 EN 980:2003

Applicable testing criteria from the AAMI standards for Transcutaneous Electrical Nerve Stimulators NS4: 1985 for Well-TENS.

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SEP - 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050435

Trade/Device Name: E-Stim II Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: June 3, 2005 Received: June 8, 2005

Dear Mr. Sheehan:

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 applicable, the electronic product radiation control provisions (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 ms letter whi anow you to begin manieting your antial equivalence of your device to a legally premarket notification. The PDA miding of cassification 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 ion Jour accil 2011 276-0120. Also, please note the regulation entitled, Contact the Office of Compullier in (21 CFR Part 807.97). You may obtain Misoraning Uy reference to premailsonsibilities under the Act from the Division of Small other general miorination on Jour responser Assistance at its toll-free number [phone] or Manufacturers, International and Ocusantery/www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nil R. P. Dyler
Mark N. Melkerson Co.

Melkerson Mark N. 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 G. Indications for Use

510(k) Number (if known): K050435

Device Name: E-Stim II

Indications For Use: The E-Stim II is intended for use in the syptomatic relief of chronic intractable pain, post traumatic acute pain, and post surgical pain.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 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, Page 1 of __ 1 __ 1 __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ and Neurological Devices

510(k) Number_KOSD435