LGXClass I
Table, Examination, Medical, Powered
21 CFR 878.4960 / General, Plastic Surgery
LGX is the FDA product code for Table, Examination, Medical, Powered, a class I device type, regulated under 21 CFR 878.4960. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and 15 recalls.
Classification record
- Product code
- LGX
- Device name
- Table, Examination, Medical, Powered
- Regulation
- 21 CFR 878.4960
- 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
- 14
- Ingested recalls
- 15
Clearances, product code LGX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1981 | 3 |
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 1 |
| 1985 | 1 |
| 1986 | 2 |
| 1988 | 2 |
| 1989 | 2 |
| 1995 | 1 |
Applicants with the most clearances
Product code LGX| Applicant | Clearances |
|---|---|
| Midmark Corp | 4 |
| Cherne Industries, Inc. | 1 |
| Coe Laboratories, Inc. | 1 |
| Enochs Mfg., Inc. | 1 |
| F. & F. Koenigkramer | 1 |
| Hamilton Industries, Inc. | 1 |
| S & W Enterprises, Inc. | 1 |
| Smr | 1 |
| Storz Instrument Co. | 1 |
| Sybron Corp. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- AKRUS GmbH & Co. KG
- Apex Health Care Mfg., Inc.
- Apramed Industria e Comercio de Aparelhos Medicos Ltda
- Brusaferri & C. SRL
- Caretek(China) Medical PLC
- Dexta Corp.
- DRE Med
- Durabuilt Medical Corp.
- Foshan Suncare Medical Products Co Ltd
- Gokler Group
- Hebei Jiede Medical Equipment Co., Ltd.
- Hengshui Shuntai Kangyuan Medical Equipment Co.,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.
