HCC — Device, Biofeedback Class II
FDA product code HCC covers "Device, Biofeedback", a Class II medical device regulated under 21 CFR 882.5050. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HCC
- Device Class
- Class II
- Regulation Number
- 882.5050
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233580 | deepwell dtx | A Breathing System (ABS) | August 1, 2024 |
| K222101 | graymatters health | Prism | March 17, 2023 |
| K180173 | palo alto health sciences | Freespira | August 23, 2018 |
| K163448 | sunstar suisse | GrindCare System | September 1, 2017 |
| K151050 | power medical devices | Pacifier Activated Lullaby (PAL®) | December 22, 2015 |
| K143507 | nfant labs | NFANT Feeding Solution | September 9, 2015 |
| K131586 | palo alto health sciences | CANARY BREATHING SYSTEM | December 10, 2013 |
| K122879 | eeg software | EEGER4 MODEL 4.3 | February 6, 2013 |
| K111687 | myotronics-noromed | EMG SYSTEM | September 29, 2011 |
| K092675 | medotech | GRINDCARE | March 3, 2010 |
| K073557 | corscience gmbh and co. kg | EEG NEUROAMP, MODEL CS10137 | February 28, 2008 |
| K071866 | kcbiomedix | NTRAINER SYSTEM | February 1, 2008 |
| K071661 | telediagnostic systems | ALPHAONE BIOFEEDBACK SYSTEM | September 5, 2007 |
| K041244 | medtronic vascular | POLYGRAM NET BIOFEEDBACK APPLICATION | August 12, 2004 |
| K020399 | intercure | RESPERATE; MODEL RR-150 | July 2, 2002 |
| K010388 | ohmeda medical | SONDREX P.A.L. SYSTEM | December 11, 2001 |
| K013399 | myotronics-noromed | MODEL MES-9000/EMG SYSTEM | November 13, 2001 |
| K012384 | bio-logic systems | EAR MUFFINS | October 15, 2001 |
| K012011 | stoelting | MODIFICATION TO A620 EEG | October 10, 2001 |
| K011964 | fasstech | INSIGHT MILLENNIUM PLUS | September 20, 2001 |