Infravib Massager Model PR-1000
by Infralux International, Inc.
510(k) K900384
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK900384 | Date27 Feb 1990 | 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- Withdrawn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
- ILY
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5500
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Infravib Massager Model PR-1000 is a therapeutic infrared heating lamp. It is designed to provide heat therapy for physical medicine applications.
This device is identified by FDA 510(k) number K900384. It is classified under product code ILY and is regulated under the physical medicine specialty.
Other devices from Infralux International, Inc.
Questions
AI-generated answers, 21 Sep 2026
What is the primary function of the Infravib Massager PR-1000?
The PR-1000 is a therapeutic infrared heating lamp specifically engineered to provide heat therapy for physical medicine applications. It utilizes infrared technology to deliver targeted heat to the treatment area.
Is this device cleared for clinical use?
Yes, the Infravib Massager Model PR-1000 has received FDA 510(k) clearance under the number K900384. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.
How is this device classified for regulatory purposes?
The device is classified under product code ILY and falls under the physical medicine specialty. This classification is used by the FDA to categorize the device based on its intended use and the clinical environment in which it is applied.