Bio-Mat 2000
510(k) K072534
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK072534 | Date8 Feb 2008 | 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- Withdrawn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
- IRT
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5740
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Bio-Mat 2000 is a powered heating pad classified under the nomenclature code IRT (Infrared Therapy Device) and intended for physical medicine applications. It delivers controlled thermal therapy to promote relaxation, reduce muscle tension, and alleviate discomfort in targeted areas of the body.
This device is supplied as a reusable, non-sterile medical instrument and is designed for use in clinical and home settings. It operates under FDA clearance (510(k) K072534) and adheres to regulatory standards for powered heating devices, with no specific MRI safety restrictions noted. Storage and maintenance instructions are detailed in the user manual.
Questions
AI-generated answers, 18 Sep 2026
What types of discomfort can the Bio-Mat 2000 help alleviate, and is it suitable for both clinical and home use?
The Bio-Mat 2000 is designed to deliver controlled thermal therapy for physical medicine applications, specifically to promote relaxation, reduce muscle tension, and alleviate discomfort in targeted areas of the body. Since it is classified as a reusable, non-sterile device, it is approved for use in both clinical settings (like physical therapy offices) and home environments, making it versatile for patients managing chronic or acute muscle-related discomfort.
How is the Bio-Mat 2000 different from other heating pads, and what makes it suitable for professional or home physical therapy?
Unlike traditional heating pads, the Bio-Mat 2000 is a powered infrared therapy device (classified under product code IRT), which means it delivers focused thermal energy to deeper tissue layers for more effective relaxation and muscle tension relief. Its FDA clearance under the Physical Medicine advisory committee ensures it meets regulatory standards for controlled thermal therapy, making it a reliable choice for both clinical and home physical therapy applications.
Is the Bio-Mat 2000 safe to use around MRI machines, and how should it be stored and maintained?
The Bio-Mat 2000 does not have any specific MRI safety restrictions mentioned in its documentation, but users should always verify compatibility with their MRI facility’s guidelines before use. Since it is a reusable, non-sterile device, proper storage and maintenance are outlined in the included user manual to ensure longevity and safe operation. Regular cleaning and adherence to the manufacturer’s instructions will help maintain its performance.
Can the Bio-Mat 2000 be used repeatedly, and if so, what care instructions should be followed?
Yes, the Bio-Mat 2000 is designed as a reusable device, meaning it can be used multiple times for different patients or applications. However, because it is non-sterile, it should not be used on open wounds or in sterile procedures. To ensure safe and effective use, follow the manufacturer’s cleaning and maintenance guidelines provided in the user manual, which likely include instructions on disinfection (if applicable) and proper storage to prevent damage or contamination.