FZKClass I
Chair, Surgical, Non-Electrical
21 CFR 878.4950 / General, Plastic Surgery
FZK is the FDA product code for Chair, Surgical, Non-Electrical, a class I device type, regulated under 21 CFR 878.4950. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- FZK
- Device name
- Chair, Surgical, Non-Electrical
- Regulation
- 21 CFR 878.4950
- Device class
- Class I
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 0
Clearances, product code FZK
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1996 | 1 |
Applicants with the most clearances
Product code FZK| Applicant | Clearances |
|---|---|
| KEYMED (Medical & Industrial Equipment) Ltd | 1 |
| Neutral Pos-Chair Co. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- A & i Industries Ltd
- Aspen Surgical Products, Inc.
- CC Hsing Company Limited
- GF Health Products, Inc.
- GUILIN YIKESHI Medical Device CO Ltd
- Industrias Apson S.A de C.V
- JEDMED Instrument Company
- Lakong Medical Devices Co., Ltd.
- Savion Industries (1987), Ltd.
- Shanghai Greeloy Industry Co., Ltd
- TPC Advanced Technology, Inc.
- United Poly Engineering Pvt. Ltd.
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.
