POINTER EXCEL

K060517 · Lhasa Oms, Inc. · GZJ · Jun 19, 2006 · Neurology

Device Facts

• Record ID: K060517
• Device Name: POINTER EXCEL
• Applicant: Lhasa Oms, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Jun 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pointer-Excel is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.

Device Story

Pointer Excel is a transcutaneous electrical nerve stimulator (TENS) for pain management. Device delivers electrical impulses to patient skin via electrodes to modulate pain signals. Operated by clinician or patient for symptomatic relief of chronic intractable, postoperative, and acute pain. Device functions as a non-invasive pain management tool; output intensity and frequency are adjusted by user to achieve therapeutic effect. Benefits include reduction of pain symptoms without pharmacological intervention.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use consistent with predicate TENS devices.

Technological Characteristics

Transcutaneous electrical nerve stimulator (TENS); electrical output for pain relief; handheld form factor; class II device per 21 CFR 882.5890.

Indications for Use

Indicated for symptomatic relief of chronic intractable pain, postoperative pain, and acute pain in patients requiring transcutaneous electrical nerve stimulation.

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features a stylized eagle with three stripes emanating from its head, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 19 2006

Lhasa OMS, Inc. % Mr. Mark W. Sheehan Regulatory Affairs Officer 230 Libbey Parkway Weymouth, Massachusetts 02189

Re: K060517

Trade/Device Name: Pointer Excel Regulatory Number: 21 CFR 882.5890 Regulatory Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: June 5, 2006 Received: June 6. 2006

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.

{1}------------------------------------------------

Page 2 - Mr. Mark W. Sheehan

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/industry/support/index.html.

Sincerely yours,

Hubert Lemmons

Mark N. Molkerson

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

{2}------------------------------------------------

## F. Indications for Use

510(k) Number (if known): K060517 Device Name: Pointer Excel

Indications for Use:

The Pointer-Excel is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.

Prescription Use X . AND/OR !1 CFR 810 Subpart D) (21 CFR 801 Subpart C)

Over-The-Counter Use (Part

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

> Concurrence of CDRH, Office of Dev eneral, Restorative. and Neurological Device

> > Page 1 of 1

510(k) Number k060517