MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM by DURTECH SYSTEM CORP.

The DT-1200 series 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, (available for DT-1200, DT-1200M and DT-1200PM) the DT-1200 is indicated for the following conditions:

Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining or increasing range of motion

As a TENS device, (available for DT-1200T and DT-1200T and DT-1200PT) the DT-1200 is indicated for the following conditions:

Symptomatic relief and management of chronic, intractable pain
Adjunctive treatment for post-surgical and post-trauma acute pain

Device Description

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for the DT-1200 series device. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. 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

2006 JAN 5

2006

DURTECH System Corp. c/o Mr. Marc M. Mouser Underwriters Labratories Inc. 2600 N.W. Lake Road Camas, Washington 98607

Re: K053285

Trade/Device Name: DT-1200 series Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle stimulator Regulatory Class: II Product Codes: IPF, GZJ Dated: December 20, 2005 Received: December 21, 2005

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 (OS) 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. 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 (240) 276-0120. Also, please note the regulation entitled, OMisbranding 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 (800) 638 2041 or (301) 443 6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Signature

Sor 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): 1053285

Device Name: DT-1200 series

Indication For Use:

As a EMS device, (available for DT-1200, DT-1200M and DT-1200PM) the DT-1200 is indicated for the following conditions:

· Relaxation of muscle spasms
· Prevention or retardation of disuse atrophy
Increasing local blood circulation
· Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining or increasing range of motion

As a TENS device, (available for DT-1200T and DT-1200T and DT-1200PT) the DT-1200 is indicated for the following conditions:

· Symptomatic relief and management of chronic, intractable pain
Adjunctive treatment for post-surgical and post-trauma acute pain

Prescription Use X 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)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K053285

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).