Fx-2 Nms (2CHANNEL Table Model)
by Fx-2 510(k)
Active
510(k) K945509
Overview
The Fx-2 Nms 2 Channel Table Model is a powered muscle stimulator. It is designed to provide electrical stimulation to muscles for physical medicine applications.
This device is supplied as a table model unit and has received FDA 510(k) clearance under K945509. It is classified as a class 2 device within the physical medicine specialty.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK945509 | Date2 May 1995 | 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- Withdrawn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
- 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
Other devices from Fx-2
Questions
What is the primary function of the FX-2 NMS 2 Channel Table Model?
This device is a powered muscle stimulator engineered to deliver electrical stimulation to muscles. It is specifically intended for use within physical medicine applications to assist in therapeutic muscle treatment.
How is the FX-2 NMS supplied to clinical environments?
The device is supplied as a stationary table model unit. This configuration is designed for clinical settings where a stable, powered platform is required for consistent muscle stimulation therapy.
What is the regulatory status of this muscle stimulator?
The FX-2 NMS 2 Channel Table Model has received FDA 510(k) clearance under K945509. It is classified as a class 2 device within the physical medicine specialty, indicating it has been found substantially equivalent to legally marketed predicate devices.