BX-600 EMS
by Bloomex International, Inc. 510(k)
Active
510(k) K832976
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK832976 | Date25 Nov 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
Overview
AI-generated summary, 1 Oct 2026
The BX-600 EMS is an Electrical Muscle Stimulator (EMS), a device designed to deliver low-energy electrical impulses to stimulate muscle contraction. It falls under the Physical Medicine category and is intended for therapeutic applications, such as muscle re-education, pain management, and improving circulation. By applying controlled electrical currents, it aids in muscle activation and recovery without invasive procedures. The device is classified under product code IPF in the FDA’s regulatory framework.
The BX-600 EMS is supplied as a reusable medical device and is cleared for use in clinical and home settings under FDA 510(k) clearance (K832976). It was granted Substantially Equivalent (SESE) status by the Physical Medicine (PM) Advisory Committee in 1983. No specific sterility or single-use requirements are noted in the regulatory submission, though proper cleaning and maintenance are implied for reusable devices. No MRI safety or size specifications are documented in the available data.
Other devices from Bloomex International, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the BX-600 EMS used for?
The BX-600 EMS is an Electrical Muscle Stimulator designed to stimulate muscle contraction through low-energy electrical impulses. It is primarily used for therapeutic applications such as muscle re-education, pain management, and enhancing circulation. By applying controlled electrical currents, it helps activate muscles and supports recovery without invasive procedures.
Is the BX-600 EMS reusable or single-use?
The BX-600 EMS is supplied as a reusable medical device. Since it is not classified as single-use, proper cleaning and maintenance are essential to ensure its continued safe and effective operation in both clinical and home settings.
What regulatory clearance does the BX-600 EMS hold?
The BX-600 EMS holds FDA 510(k) clearance under the product code IPF, with a clearance number of K832976. It was granted Substantially Equivalent (SESE) status by the Physical Medicine (PM) Advisory Committee in 1983, indicating it meets regulatory standards for therapeutic electrical muscle stimulators.
Does the BX-600 EMS require special storage or handling?
While no specific sterility requirements are documented for the BX-600 EMS, as a reusable device, it must be cleaned and maintained properly to prevent contamination and ensure functionality. Standard storage practices for medical devices should be followed, including protection from moisture, extreme temperatures, and physical damage.
Are there different models or sizes available for the BX-600 EMS?
The available data does not specify multiple models or sizes for the BX-600 EMS. It is a single device model designed for general therapeutic use in muscle stimulation applications. For precise specifications, refer to the manufacturer’s instructions or technical documentation.