MAGBODY DT-600

K053284 · Durtech System Corp. · GZJ · Mar 10, 2006 · Neurology

Device Facts

• Record ID: K053284
• Device Name: MAGBODY DT-600
• Applicant: Durtech System Corp.
• Product Code: GZJ · Neurology
• Decision Date: Mar 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The DT-600 is a multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (EMS) and transcutaneous electrical nerve stimulation (TENS). As a EMS device, DT-600 is indicated for the following conditions: - Relaxation of muscle spasms As a TENS device, the DT-600 is indicated for the following conditions: - For symptomatic relief of chronic intractable pain.

Device Story

DT-600 is a multifunction electrotherapy device providing neuromuscular electrical stimulation (EMS) and transcutaneous electrical nerve stimulation (TENS). Device delivers electrical impulses to patient via electrodes to treat muscle spasms and chronic intractable pain. Operated by healthcare professionals or patients; used in clinical or home settings. Output parameters controlled by user to manage stimulation intensity and mode. Benefits include non-pharmacological pain management and muscle relaxation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Multifunction electrotherapy device; powered muscle stimulator (21 CFR 890.5850); provides EMS and TENS modalities; electrical output via electrodes.

Indications for Use

Indicated for patients requiring relaxation of muscle spasms (EMS) or symptomatic relief of chronic intractable pain (TENS).

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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2006

Durtech Systems Corp. c/o Underwriters Laboratories, Inc Mr. Marc M. Mouser Senior Project Engineer, Medical Devices 2600 NW Lake Road Camas, Washington 98607

Re: K053284

Trade/Device Name: DT-600 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: GZJ Dated: February 23, 2006 Received: February 27, 2006

Dear Mr. Mouser:

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. Marc M. Mouser

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,
Hubert Lewis

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

Enclosure

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## Indication for Use

510(K) Number (if known):

Device Name: DT-600

Indication For Use:

The DT-600 is a multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (EMSamond transcutaneous electrical nerve stimulation (TENS).

As a EMS device, DT-600 is indicated for the following conditions:

- · Relaxation of muscle spasms
As a TENS device, the DT-600 is indicated for the following conditions:

- · For symptomatic relief of chronic intractable pain.
Prescription Use ________________AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulut Lundo

ion. Division of General, Restorative, and Neurological Devices

**510(k) Number** K053284