HCCClass II
Device, Biofeedback
21 CFR 882.5050 / Neurology
HCC is the FDA product code for Device, Biofeedback, a class II device type, regulated under 21 CFR 882.5050. As of , FDA records hold 172 510(k) clearances under this code, the most recent dated , and 4 recalls.
Classification record
- Product code
- HCC
- Device name
- Device, Biofeedback
- Regulation
- 21 CFR 882.5050
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 172
- Ingested recalls
- 4
Clearances, product code HCC
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 7 |
| 1978 | 2 |
| 1979 | 2 |
| 1980 | 4 |
| 1981 | 9 |
| 1982 | 2 |
| 1983 | 7 |
| 1984 | 14 |
| 1985 | 5 |
| 1986 | 4 |
| 1987 | 5 |
| 1988 | 9 |
| 1989 | 12 |
| 1990 | 6 |
| 1991 | 6 |
| 1992 | 5 |
| 1993 | 3 |
| 1994 | 2 |
| 1995 | 16 |
| 1996 | 8 |
| 1997 | 7 |
| 1998 | 5 |
| 1999 | 5 |
| 2000 | 2 |
| 2001 | 9 |
| 2002 | 1 |
| 2004 | 1 |
| 2007 | 1 |
| 2008 | 2 |
| 2010 | 1 |
| 2011 | 1 |
| 2013 | 2 |
| 2015 | 2 |
| 2017 | 1 |
| 2018 | 1 |
| 2023 | 1 |
| 2024 | 1 |
Applicants with the most clearances
Product code HCC| Applicant | Clearances |
|---|---|
| Thought Technology Ltd. | 14 |
| Bio-Feedback Systems, Inc. | 9 |
| Moe | 6 |
| Calnor of el Paseo, Inc. | 5 |
| Fasstech | 5 |
| Verimed Holdings, Inc. | 5 |
| Stoelting Co. | 4 |
| The Prometheus Group | 4 |
| Atlas Researches, Ltd. | 3 |
| Autoject Systems, Inc. | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.