Ar-1 Physiological Prodessor
by Atlas Researches, Ltd. 510(k)
Active
510(k) K810880
Overview
The AR-1 Physiological Processor is a biofeedback device classified under neurology. It is designed to monitor and process physiological signals to provide feedback to the user.
This device is authorized via FDA 510(k) clearance under the regulation number 882.5050. It is manufactured by Atlas Researches, Ltd.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK810880 | Date27 May 1981 | 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- Withdrawn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
- HCC
- FDA applicant
- Atlas Researches , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5050
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Atlas Researches, Ltd.
Questions
What is the primary function of the AR-1 Physiological Processor?
The device is designed to function as a biofeedback tool within the field of neurology. It works by monitoring and processing a user's physiological signals to provide them with real-time feedback.
How was the AR-1 Physiological Processor authorized for use?
The device is authorized via FDA 510(k) clearance. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices under regulation number 882.5050.
What medical specialty is this device associated with?
The AR-1 Physiological Processor is classified under the neurology medical specialty, as indicated by its regulatory filing with the advisory committee for neurology.