TL250 INTERFERENTIAL/MUSCLE STIMULATOR INTERFERENTIAL CURRENT THERAPY MUSCLE STIMULATOR

• K Number: K990129
• Device Name: TL250 INTERFERENTIAL/MUSCLE STIMULATOR INTERFERENTIAL CURRENT THERAPY MUSCLE STIMULATOR
• Manufacturer: THERAPY LINK, INC.
• Date Cleared: 1999-04-12 ( 89 days)
• Product Code: LIH , IPF
• Regulation Number: 882.5890
• Type: Traditional
• Panel: Neurology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended 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

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a device called "TL250 Interferential/Muscle Stimulatory." This letter indicates that the device has been found substantially equivalent to predicate devices, allowing it to be marketed.

However, this letter does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. The letter is a regulatory approval document, not a detailed technical report of a clinical study.

Therefore,Based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them because this information is not present in the document.

The document is a regulatory approval letter (510(k) clearance) stating the device is substantially equivalent to a predicate device, but it does not detail the scientific studies, acceptance criteria, or performance data that would typically be included in a clinical study report.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a 510(k) submission document that details the performance data.

Summary

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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)

Regulation Number and Section

§ 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).