(89 days)
Not Found
Not Found
No
The document describes a device with various electrical stimulation modalities for therapeutic purposes. There is no mention of AI, ML, image processing, or any data-driven decision-making processes that would indicate the use of these technologies.
Yes
The device is intended to treat medical conditions such as muscle spasm, disuse atrophy, and pain, as well as to increase blood circulation and range of motion. These are all therapeutic applications.
No
The device's Intended Use / Indications for Use describe therapeutic applications like muscle relaxation, pain relief, and circulation improvement, not the diagnosis of medical conditions.
Unknown
The provided text only includes the Intended Use/Indications for Use. Without a Device Description, it is impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The listed indications (muscle relaxation, pain management, increasing blood circulation, etc.) describe therapeutic applications performed directly on the patient's body. IVDs, on the other hand, are used to examine specimens (like blood, urine, or tissue) taken from the body to diagnose diseases or conditions.
- Device Description: While the description is "Not Found," the listed modalities (Russian, Interferential, Hi volt, Lo volt, Microcurrent) are all types of electrical stimulation used for physical therapy and pain management, not for analyzing biological samples.
- No mention of specimen analysis: There is no mention of analyzing blood, urine, tissue, or any other biological specimen.
Therefore, this device is a therapeutic device, likely an electrical stimulator, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For Russian
- Relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education ◆
- Maintaining or increasing range of motion ●
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
For Interferential
- Symptomatic relief of chronic, intractable pain ●
- Management of pain associated with post-traumatic or post-operative . conditions
For Hi volt
- Maintaining or increasing range of motion ●
- Increasing local blood circulation ●
For Lo volt
- Maintaining or increasing range of motion
- Increasing local blood circulation ●
For Microcurrent
- Management of pain associated with post-traumatic or post-operative . conditions
- Increasing local blood circulation
Product codes
IPF, LIH
Device Description
Not Found
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
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes forming its body, representing the department's commitment to health, services, and human well-being. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 1999
Mr. Craig Seyl Therapy Link, Inc. P.O. Box 19204 Lenexa, Kansas 66215
K990129 Re: TL250 Interferential/Muscle Stimulatory Interferential Current Therapy Muscle Stimulatory Regulatory Class: II Product Codes: IPF and LIH Dated: January 4, 1999 Received: January 13, 1999
Dear Mr. Seyl:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Craig Seyl
This letter will allow you to begin marketing your device as described in your 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 marketed produced permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K990129 to the image contains the text "K990129" and "page 1 of 2" and "TL250 Interferential/Muscle Stimulator"
Statement of Indications for Use
For Russian
- Relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education ◆
- Maintaining or increasing range of motion ●
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
For Interferential
- Symptomatic relief of chronic, intractable pain ●
- Management of pain associated with post-traumatic or post-operative . conditions
For Hi volt
- Maintaining or increasing range of motion ●
- Increasing local blood circulation ●
For Lo volt
- Maintaining or increasing range of motion �
- Increasing local blood circulation ●
For Microcurrent
- Management of pain associated with post-traumatic or post-operative . conditions
- Increasing local blood circulation �
Russell J. Vayon for JZP
Prescription Use (Per 21 CFR 801.109)