FT2000 Sequencer for Muscle Stimulator
510(k) K050595
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK050595 | Date23 May 2005 | 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- Withdrawn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 FT2000 Sequencer for Muscle Stimulator is a powered electrical device classified as a muscle stimulator (product code IPF). It is designed to generate electrical impulses for neuromuscular stimulation when used in conjunction with an approved stimulator device. This device facilitates muscle relaxation, prevents or slows disuse muscle atrophy, aids in muscle re-education, and promotes local blood circulation. Its primary function is to modulate electrical signals for therapeutic muscle stimulation purposes.
The FT2000 Sequencer is intended for use in clinical settings where neuromuscular stimulation is required, typically paired with an external stimulator such as the NT2000. It is a reusable device, as indicated by its regulatory submission, and has received FDA 510(k) clearance under the Traditional review pathway. The device is not described as sterile or single-use, and no MRI safety information is provided. It is supplied as a standalone unit with no additional sterilization requirements, and its regulatory classification falls under Class II with Special Controls.
Questions
AI-generated answers, 1 Oct 2026
What is the FT2000 Sequencer used for in clinical practice?
The FT2000 Sequencer is designed to generate precise electrical impulses for neuromuscular stimulation when used alongside an external stimulator, such as the NT2000. Its primary clinical applications include facilitating muscle relaxation, preventing or slowing disuse muscle atrophy, assisting in muscle re-education, and promoting local blood circulation. This makes it particularly useful in rehabilitation settings where controlled muscle stimulation is required.
Is the FT2000 Sequencer a single-use or reusable device?
The FT2000 Sequencer is a reusable device, as indicated by its regulatory submission and classification. This means it is intended for repeated use in clinical environments, provided it is maintained and cleaned according to manufacturer guidelines. No sterilization requirements are specified, but standard infection control protocols should be followed to ensure safe reuse.
What regulatory pathway was followed for the FT2000 Sequencer’s clearance?
The FT2000 Sequencer received FDA 510(k) clearance under the Traditional review pathway, demonstrating that it was determined to be substantially equivalent to a legally marketed predicate device. The device falls under product code IPF (muscle stimulator) and is classified as Class II with Special Controls. The clearance was granted by the FDA’s Physical Medicine Advisory Committee in 2005.
How is the FT2000 Sequencer supplied, and are there any special handling requirements?
The FT2000 Sequencer is supplied as a standalone unit, meaning it does not require additional components or accessories for basic operation. Since it is reusable, it does not come pre-sterilized, and no specific sterilization instructions are provided in the available data. Clinicians should follow standard disinfection protocols to maintain hygiene between uses, ensuring the device remains safe for repeated clinical applications.
Can the FT2000 Sequencer be used with any muscle stimulator, or is it compatible only with specific models?
The FT2000 Sequencer is designed to work in conjunction with an approved stimulator device, with the NT2000 mentioned as a typical pairing in clinical settings. While the device is not explicitly restricted to the NT2000, compatibility depends on the electrical and functional specifications of the paired stimulator. Users should verify compatibility with their specific stimulator model to ensure proper operation and therapeutic outcomes.