IF8000
by Dan Med, Inc. 510(k)
Active
510(k) K991241
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991241 | Date2 Nov 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-1874-2014
Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to operate, and in some instances,overheating and becoming hot to the touch.
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, 26 Sep 2026
The IF8000 is a muscle stimulator device that is powered and intended for use with reusable, self-adhesive electrodes. It is classified as a Class II medical device under the product code IPF and is designed for physical medicine applications.
The IF8000 is supplied with reusable electrodes that can be extended by adding water to the adhesive surface after each use. The device received FDA 510(k) clearance on November 2, 1999, with the K number K991241, and is manufactured by Dan Med, Inc. in Denver, Colorado.
Other devices from Dan Med, Inc.
Questions
AI-generated answers, 26 Sep 2026
What is the IF8000 muscle stimulator device used for?
The IF8000 is a muscle stimulator device designed for physical medicine applications. It is powered and intended for use with reusable, self-adhesive electrodes to provide therapeutic muscle stimulation treatments.
How are the electrodes for the IF8000 device maintained?
The IF8000 is supplied with reusable electrodes that can be extended by adding water to the adhesive surface after each use. This allows for multiple uses while maintaining the electrode's effectiveness.
What is the regulatory status of the IF8000 device?
The IF8000 is classified as a Class II medical device under product code IPF. It received FDA 510(k) clearance on November 2, 1999, with K number K991241, making it substantially equivalent to other devices on the market.
Who manufactures the IF8000 muscle stimulator and where is it produced?
The IF8000 is manufactured by Dan Med, Inc., located in Denver, Colorado. The company produces this muscle stimulator device at their facility at 4 W. Dry Creek Cir., Suite 260, Denver, CO 80120.