TENS PRO 900

K023726 · Acumed Medical Supplies , Ltd. · GZJ · Jun 17, 2003 · Neurology

Device Facts

• Record ID: K023726
• Device Name: TENS PRO 900
• Applicant: Acumed Medical Supplies , Ltd.
• Product Code: GZJ · Neurology
• Decision Date: Jun 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

for use as an adjunct device for the symptomatic relief and management of chronic intractable pain

Device Story

TENS Pro 900 is a transcutaneous electrical nerve stimulator (TENS) used for pain management. Device delivers electrical impulses to nerves via skin electrodes to provide symptomatic relief for chronic intractable pain. Operated by patients or clinicians in clinical or home settings. Output consists of adjustable electrical stimulation parameters. Healthcare providers use device to manage patient pain as an adjunct therapy, potentially reducing reliance on other pain management interventions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Transcutaneous electrical nerve stimulator (TENS) device; Class II; Product Code GZJ; 21 CFR 882.5890. Electrical stimulation output via skin electrodes.

Indications for Use

Indicated for the symptomatic relief and management of chronic intractable 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.

Submission Summary (Full Text)

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JUN 1 7 2003

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Acumed Medical Supplies Ltd. c/o Mr. Richard Keen Compliance Consultants 1151 Hope Street Stamford, Connecticut 06907

Re: K023726

Trade/Device Name: TENS Pro 900™ Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: March 13, 2003 Received: March 19, 2003

Dear Mr. Keen:

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 docs 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. Richard Keen

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,

Mark N. Melkerson

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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## Exhibit 2

510(k) Number (if known): K023726

Device Name: TENS Pro 900

Indications for Use:

for use as an adjunct device for the symptomatic relief and management of chronic intractable d. pain

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Millkuno
(Division Sign Off)

sion Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number_