IPFClass II
Stimulator, Muscle, Powered
21 CFR 890.5850 / Physical Medicine
IPF is the FDA product code for Stimulator, Muscle, Powered, a class II device type, regulated under 21 CFR 890.5850. As of , FDA records hold 548 510(k) clearances under this code, the most recent dated , and 7 recalls.
Classification record
- Product code
- IPF
- Device name
- Stimulator, Muscle, Powered
- Regulation
- 21 CFR 890.5850
- Device class
- Class II
- Review panel
- Physical Medicine
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 548
- Ingested recalls
- 7
Clearances, product code IPF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 3 |
| 1977 | 3 |
| 1978 | 9 |
| 1979 | 5 |
| 1980 | 9 |
| 1981 | 19 |
| 1982 | 25 |
| 1983 | 10 |
| 1984 | 22 |
| 1985 | 19 |
| 1986 | 24 |
| 1987 | 17 |
| 1988 | 11 |
| 1989 | 18 |
| 1990 | 28 |
| 1991 | 11 |
| 1992 | 14 |
| 1993 | 18 |
| 1994 | 14 |
| 1995 | 17 |
| 1996 | 10 |
| 1997 | 10 |
| 1998 | 11 |
| 1999 | 8 |
| 2000 | 5 |
| 2001 | 15 |
| 2002 | 21 |
| 2003 | 27 |
| 2004 | 9 |
| 2005 | 11 |
| 2006 | 1 |
| 2007 | 8 |
| 2008 | 6 |
| 2009 | 7 |
| 2010 | 4 |
| 2011 | 4 |
| 2012 | 4 |
| 2013 | 10 |
| 2014 | 4 |
| 2015 | 3 |
| 2016 | 7 |
| 2017 | 5 |
| 2018 | 5 |
| 2019 | 4 |
| 2020 | 9 |
| 2021 | 15 |
| 2022 | 7 |
| 2023 | 9 |
| 2024 | 7 |
| 2025 | 3 |
| 2026 | 3 |
Applicants with the most clearances
Product code IPF| Applicant | Clearances |
|---|---|
| Rich-Mar Corp. | 17 |
| Bloomex International, Inc. | 14 |
| Chattanooga Group, Inc. | 14 |
| Mettler Electronics Corp | 13 |
| Maximum Performance Technologies, Mpts, Inc. | 11 |
| Firstkind Ltd | 10 |
| RS Medical | 8 |
| Bio-Medical Research, Ltd. | 7 |
| BioMedical Life Systems Inc. | 7 |
| Electro Med Supply, Inc. | 7 |
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.
