KIAClass I
Cover, Cast
21 CFR 880.6185 / General Hospital
KIA is the FDA product code for Cover, Cast, a class I device type, regulated under 21 CFR 880.6185. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- KIA
- Device name
- Cover, Cast
- Regulation
- 21 CFR 880.6185
- Device class
- Class I
- Review panel
- General Hospital
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- Yes
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code KIA
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
Applicants with the most clearances
Product code KIA| Applicant | Clearances |
|---|---|
| B & F Medical Products, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- am foam products
- Apothecary Products, LLC
- Asia Quality & Technical Services Inc. (Asia Technical Services)
- Boen Healthcare Co., Ltd.
- Brownmed
- BSN Medical
- CBR Enterprise Limited
- Changzhou DSB Medical Co., Ltd
- Chengdu Cryo-Push Medical Technology Co.,Ltd
- Compass Health Brands (Corporate Office)
- Debo Medical Technology (Shijiazhuang) Co., Ltd.
- DJO, LLC
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.
