TL250 Interferential/Muscle Stimulator
by Therapy Link, Inc. 510(k)
Active
510(k) K990129
Overview
The TL250 Interferential/Muscle Stimulator is an interferential current therapy device designed to deliver electrical stimulation for neuromuscular applications. It generates interferential currents to promote muscle re-education, reduce spasm, and improve local circulation, aiding in rehabilitation and pain management.
This device is intended for use by healthcare professionals in clinical settings and is supplied as a reusable medical instrument. It has received FDA 510(k) clearance under the Traditional 510(k) Review pathway, classified as a Class II device. The TL250 operates via electrodes applied to patient tissues and is regulated under the interferential current therapy category (regulation number 882.5890)
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK990129 | Date12 Apr 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- TL250 Interferential/Muscle Stimulator Interferential Current Therapy Muscle Stimulator
- 510(k) Number
- FDA Product Code
- LIH
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Questions
What clinical applications is the TL250 Interferential/Muscle Stimulator primarily used for in healthcare settings?
The TL250 is designed to deliver interferential current therapy for neuromuscular applications, helping to promote muscle re-education, alleviate muscle spasms, and improve local circulation. These features make it useful in rehabilitation programs and pain management for patients under the care of healthcare professionals, particularly in neurology-related treatments.
Is the TL250 a single-use or reusable device, and how should it be maintained?
The TL250 is supplied as a reusable medical instrument, meaning it is intended for repeated use in clinical settings. Since it is reusable, proper cleaning, disinfection, and maintenance protocols must be followed as per manufacturer guidelines to ensure safety and functionality between uses.
What regulatory pathway was followed for FDA clearance of the TL250, and how is it classified?
The TL250 received FDA clearance under the Traditional 510(k) Review pathway and is classified as a Class II device. This classification indicates it poses moderate risk and requires compliance with specific regulatory controls to ensure safety and effectiveness in its intended neuromuscular applications.
How is the TL250 delivered to patients, and what components are involved in its operation?
The TL250 operates by applying electrodes to patient tissues, generating interferential currents to stimulate muscles and tissues. The device itself is a reusable medical instrument, and its functionality relies on the proper placement and connection of electrodes to the patient’s skin for therapeutic effects.