IMEClass I
Pack, Hot Or Cold, Reusable
21 CFR 890.5700 / Physical Medicine
IME is the FDA product code for Pack, Hot Or Cold, Reusable, a class I device type, regulated under 21 CFR 890.5700. As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and 12 recalls.
Classification record
- Product code
- IME
- Device name
- Pack, Hot Or Cold, Reusable
- Regulation
- 21 CFR 890.5700
- Device class
- Class I
- Review panel
- Physical Medicine
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- Yes
- Third party review eligible
- No
- Ingested clearances
- 27
- Ingested recalls
- 12
Clearances, product code IME
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1979 | 3 |
| 1980 | 3 |
| 1981 | 3 |
| 1982 | 4 |
| 1983 | 7 |
| 1986 | 1 |
| 1988 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 2 |
Applicants with the most clearances
Product code IME| Applicant | Clearances |
|---|---|
| Fred Sammons, Inc. | 4 |
| Ackrad Laboratories | 1 |
| BD Becton Dickinson Vacutainer Systems Preanalytic | 1 |
| Danek Medical, Inc. | 1 |
| Delta Medical Industries | 1 |
| Dr. Micheal A. Sabia | 1 |
| Ferguson Medical | 1 |
| Friendmed Products | 1 |
| Hospital Marketing Services Co., Inc. | 1 |
| Igloo Corp. | 1 |
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.