(41 days)
Not Found
Not Found
No
The document describes a standard electrotherapy device with various stimulation modes and does not mention any AI or ML capabilities in its intended use, device description, or performance study summaries.
Yes
The device is indicated for various therapeutic purposes such as muscle relaxation, pain relief, and prevention of disuse atrophy.
No
The device's intended uses are for treatment (muscle relaxation, pain relief, etc.) using electrical stimulation, not for diagnosing conditions.
No
The device description explicitly states it is a "multifunction electrotherapy device," which implies hardware components for delivering electrical stimulation (EMS and TENS).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the DT-1200 series is an electrotherapy device that uses electrical stimulation (EMS and TENS) applied to the body for therapeutic purposes (muscle stimulation, pain relief).
- Intended Use: The intended uses listed are all related to applying electrical stimulation to the body for treatment of various physical conditions. There is no mention of analyzing samples from the body.
Therefore, the DT-1200 series falls under the category of therapeutic medical devices, not in vitro diagnostics.
No.
A Predetermined Change Control Plan (PCCP) is a voluntary program that allows for pre-specified modifications to a device's hardware, software, or indications for use without requiring a new 510(k) submission for each change. There is no mention or indication of such a plan in this clearance letter. The information provided is typical for a standard 510(k) clearance, detailing the intended use, device description, and other common regulatory elements, but it does not specify any provisions for a PCCP.
Intended Use / Indications for Use
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
Product codes
IPF, GZJ
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
Indication for Use
510(K) Number (if known): 1053285
Device Name: DT-1200 series
Indication For Use:
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
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