VectorSurge 4 Interferential Therapy Unit Model VS 460
by Metron Medical Australia, Pty, Ltd.
510(k) K003260
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK003260 | Date22 Feb 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IPF
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The VectorSurge 4 Interferential Therapy Unit Model VS 460 is a powered muscle stimulator classified as an interferential therapy device. It delivers electrical currents through electrodes to induce repetitive muscle contractions, aiding in pain relief and muscle rehabilitation. Designed for physical medicine applications, it employs interferential current technology to penetrate deeper tissue layers compared to conventional stimulators. This modality is commonly used to manage chronic pain, reduce inflammation, and improve muscle function in clinical settings.
The device is supplied as a reusable medical instrument intended for use in clinical environments such as physical therapy clinics, rehabilitation centers, and hospitals. It operates under FDA 510(k) clearance (K003260) and falls under product code IPF, classified as a Class II Special Controls device. No specific sterility requirements are noted in the regulatory data, though standard infection control practices should be followed during use. Storage and maintenance instructions are manufacturer-specific and not detailed in the provided data.
Other devices from Metron Medical Australia, Pty, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the VectorSurge 4 Interferential Therapy Unit VS 460 used for?
The VectorSurge 4 Interferential Therapy Unit (VS 460) is designed to deliver interferential current therapy, which induces repetitive muscle contractions through electrodes. This modality is primarily used to manage chronic pain, reduce inflammation, and improve muscle function by penetrating deeper tissue layers compared to conventional stimulators. It is commonly applied in physical medicine for rehabilitation and pain management in clinical environments like physical therapy clinics, hospitals, and rehabilitation centers.
Is the VectorSurge 4 Interferential Therapy Unit VS 460 reusable or single-use?
The VectorSurge 4 Interferential Therapy Unit (VS 460) is supplied as a reusable medical instrument. It is intended for use in clinical settings where multiple patients may benefit from its applications, such as physical therapy clinics, rehabilitation centers, and hospitals. Reusability allows for cost-effective use across various patients while adhering to standard infection control practices during each session.
What regulatory approval does the VectorSurge 4 Interferential Therapy Unit VS 460 hold?
The VectorSurge 4 Interferential Therapy Unit (VS 460) holds FDA 510(k) clearance under the reference number K003260. This clearance indicates that the device is classified as substantially equivalent to a legally marketed predicate device and falls under product code IPF, categorized as a Class II Special Controls device. The clearance was granted by the Physical Medicine Advisory Committee in 2001.
Are there any specific sterility requirements for the VectorSurge 4 Interferential Therapy Unit VS 460?
The regulatory data for the VectorSurge 4 Interferential Therapy Unit (VS 460) does not specify any particular sterility requirements. However, as with all reusable medical devices used in clinical settings, adherence to standard infection control practices is strongly recommended. This includes proper cleaning, disinfection, and maintenance procedures to ensure safe and hygienic use across multiple patients.
Where can the VectorSurge 4 Interferential Therapy Unit VS 460 be used?
The VectorSurge 4 Interferential Therapy Unit (VS 460) is intended for use in clinical environments where physical medicine and rehabilitation are provided. This includes physical therapy clinics, rehabilitation centers, and hospitals. Its design supports applications in managing chronic pain, reducing inflammation, and improving muscle function through interferential current therapy.