Self Regulation Sys Prof Series Biofeedback Device
by Self Regulation Systems, Inc.
510(k) K870793
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK870793 | Date1 May 1987 | 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- Withdrawn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
- HCC
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5050
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Professional Series Biofeedback Device is a biofeedback instrument classified under FDA product code HCC, designed to assist in the assessment and training of physiological self-regulation. It provides real-time feedback on physiological signals such as electromyography (EMG), electrodermal activity (EDA), or other measurable bioelectric responses, aiding users in developing voluntary control over these functions for therapeutic or research purposes.
This device is intended for use in clinical or research settings and is supplied as a reusable medical instrument. It operates under Class II regulatory classification (21 CFR 882.5050) and has received FDA 510(k) clearance (K870793). The device is not single-use and requires proper maintenance, calibration, and storage as per manufacturer guidelines to ensure accuracy and reliability. Multiple model variants are registered, each adhering to the same regulatory framework.
Other devices from Self Regulation Systems, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Professional Series Biofeedback Device used for?
The Professional Series Biofeedback Device is designed to assist in the assessment and training of physiological self-regulation. It provides real-time feedback on measurable bioelectric responses such as electromyography (EMG) and electrodermal activity (EDA), helping users develop voluntary control over these functions. This is particularly useful in therapeutic and research settings for conditions related to neurology, such as muscle tension, stress response, or other biofeedback-based interventions.
How is the Professional Series Biofeedback Device supplied and is it single-use?
The device is supplied as a reusable medical instrument, not intended for single-use. Reusability requires adherence to manufacturer guidelines for proper maintenance, calibration, and storage to ensure accuracy and reliability over multiple uses. This design supports long-term clinical or research applications where consistent performance is critical.
What models or variants of the Professional Series Biofeedback Device are available?
Multiple model variants of the Professional Series Biofeedback Device are registered, each adhering to the same regulatory framework (FDA 510(k) clearance under product code HCC). These variants are differentiated by unique registration numbers, such as 3039260720, 3015497638, and others listed in the regulatory records. The specific model should be selected based on clinical or research requirements, ensuring compatibility with intended physiological signals (e.g., EMG or EDA).
How should the Professional Series Biofeedback Device be stored?
The device must be stored according to manufacturer guidelines to preserve functionality and sterility (where applicable). Since it is reusable, storage should include protection from physical damage, environmental contaminants, and electromagnetic interference. Proper calibration and maintenance checks should be documented before and after storage periods to ensure reliability for clinical or research use.
What regulatory pathway does the Professional Series Biofeedback Device follow?
The device follows the FDA 510(k) clearance pathway, classified under product code HCC and regulatory number 882.5050. It was reviewed by the Neurology (NE) Advisory Committee and granted clearance as substantially equivalent to a predicate device. This classification ensures it meets FDA standards for safety and effectiveness in its intended use for biofeedback applications in neurology.