IOEClass I
Bars, Parallel, Exercise
21 CFR 890.5370 / Physical Medicine
IOE is the FDA product code for Bars, Parallel, Exercise, a class I device type, regulated under 21 CFR 890.5370. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- IOE
- Device name
- Bars, Parallel, Exercise
- Regulation
- 21 CFR 890.5370
- 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
- 2
- Ingested recalls
- 0
Clearances, product code IOE
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1983 | 1 |
Applicants with the most clearances
Product code IOE| Applicant | Clearances |
|---|---|
| Kaye Products, Inc. | 1 |
| Will Ross Co. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Armedica Mfg.
- Clinton Industries, Inc
- DJO, LLC
- Dong Guan Yunzhishang Health Technology Co.,Ltd.
- H/P/Cosmos Sports & Medical GmbH
- Hangzhou Zhongzhi Industry Co.,Ltd
- Hausmann Enterprises, LLC
- IPE Plastic & Hardware Industy, Ltd
- Jasan International Limited
- MCR Internacional SA de CV
- MJM International Corporation
- Mor-Medical International
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
