K233337 is an FDA 510(k) clearance for the Freespira Breathing System. This device is classified as a Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety (Class II - Special Controls, product code SEN).
Submitted by Freespira, Inc. (Kirkland, US). The FDA issued a Cleared decision on April 24, 2025, 573 days after receiving the submission on September 29, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5050. A Biofeedback Device For Adjunctive Treatment Of Patient-reported Symptoms Associated With Stress And Anxiety Is Intended To Provide Feedback To Users With Patient-reported Symptoms Associated With Stress And Anxiety On A Physiological Measurement As A Relaxation Treatment For The Reduction Of Stress And Anxiety..
| 510(k) Number | K233337 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2023 |
| Decision Date | April 24, 2025 |
| Days to Decision | 573 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | SEN - Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5050 |
| Definition | A Biofeedback Device For Adjunctive Treatment Of Patient-reported Symptoms Associated With Stress And Anxiety Is Intended To Provide Feedback To Users With Patient-reported Symptoms Associated With Stress And Anxiety On A Physiological Measurement As A Relaxation Treatment For The Reduction Of Stress And Anxiety. |