(105 days)
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.
The DT-600 is a multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (EMSamond transcutaneous electrical nerve stimulation (TENS).
The provided document is a 510(k) clearance letter from the FDA for a device named DT-600. It asserts substantial equivalence to a predicate device and outlines the indications for use. However, this document does not contain any information regarding specific acceptance criteria, study data, sample sizes, expert qualifications, or details about comparative effectiveness studies (MRMC or standalone).
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using only the provided text. The document is solely a regulatory clearance letter, not a study report or clinical trial summary.
To answer your questions, I would need additional documentation such as:
- A clinical study report
- A summary of safety and effectiveness (SSE) or a substantial equivalence submission (510(k) summary) that would typically accompany such a clearance letter and include details about performance testing.
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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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
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.(b)
Classification. Class II (performance standards).