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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
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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.

§ 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).