Product code HME
- Device name
- Chair, Ophthalmic, Ac-Powered
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.1140
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K930449 | MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR | Marco Ophthalmic, Inc. | 1993-07-06 |
| K914416 | BREATH-EASY, MODIFICATION | Icor AB | 1992-06-23 |
| K894018 | RELIANCE(R) 6200 EXAMINATION CHAIR | Reliance Medical Products, Inc. | 1989-09-12 |
| K870112 | STORZ ENT/OPHTHALMIC MAXI CHAIR | Storz Instrument Co. | 1987-02-12 |
| K864494 | MODEL 6500 OPTHALMIC CHAIR | Koken Mfg Company, Inc. | 1986-12-15 |
| K864574 | MAC 150E OPTHALMIC CHAIR | Koken Mfg Company, Inc. | 1986-12-15 |
| K863728 | THE ERGOSYSTEM CHAIR | Charles D. Bell, Inc. | 1986-10-31 |
| K863008 | -OM WEST 2000 GNATUS CHAIR | Sds Dental, Inc. | 1986-09-24 |
| K853743 | TECHNA VISION, INC. ELECTRIC CHAIR | Techna Vision | 1985-10-17 |
| K853149 | RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 | F. & F. Koenigkramer | 1985-09-05 |
| K853150 | RELIANCE 6100 | F. & F. Koenigkramer | 1985-09-05 |
| K853151 | RELIANCE 5000 | F. & F. Koenigkramer | 1985-09-05 |
| K842045 | WOODLYN CLASSIC EXAM. CHAIR | Woodlyn, Inc. | 1984-06-19 |
| K833539 | DOWING OPHTHALMIC CHAIR AC-POWERED | Vision Health Technology | 1984-03-05 |
| K801638 | A O CUSTOM II CHAIR AND STAND | American Optical Corp. | 1980-08-13 |
| K781801 | MAXI-CHAIR | Surgical Mechanical Research, Inc. | 1978-11-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08436566190039 | TOPCON | ANTONI CARLES SA | 2026-06-01 |
| 08436566190046 | TOPCON | ANTONI CARLES SA | 2026-06-01 |
| 08436566190053 | TOPCON | ANTONI CARLES SA | 2026-06-01 |
| 08436566190022 | TOPCON | ANTONI CARLES SA | 2026-06-01 |
| 00850003069760 | OC-2300 | TOPCON HEALTHCARE INC | 2026-05-06 |
| 00850003069753 | OC-2300 | TOPCON HEALTHCARE INC | 2026-05-06 |
| 00850053428760 | OC-2200 | TOPCON HEALTHCARE INC | 2025-10-31 |
| 00850053428876 | OC-2200 | TOPCON HEALTHCARE INC | 2025-10-31 |
| 00850053428869 | OC-2200 | TOPCON HEALTHCARE INC | 2025-10-31 |
| 00850053428845 | OC-2200 | TOPCON HEALTHCARE INC | 2025-10-31 |
| 00850053428838 | OC-2200 | TOPCON HEALTHCARE INC | 2025-10-31 |
| 00850053428821 | OC-2200 | TOPCON HEALTHCARE INC | 2025-10-31 |
| 00850053428814 | OC-2200 | TOPCON HEALTHCARE INC | 2025-10-31 |
| 00850053428807 | OC-2200 | TOPCON HEALTHCARE INC | 2025-10-31 |
| 00850053428791 | OC-2200 | TOPCON HEALTHCARE INC | 2025-10-31 |
| 00850053428784 | OC-2200 | TOPCON HEALTHCARE INC | 2025-10-31 |
| 00850053428777 | OC-2200 | TOPCON HEALTHCARE INC | 2025-10-31 |
| 00850003069654 | OC-2200 | TOPCON HEALTHCARE INC | 2025-10-31 |
| 00850053428753 | OC-2200 | TOPCON HEALTHCARE INC | 2025-10-31 |
| 00850053428746 | OC-2200 | TOPCON HEALTHCARE INC | 2025-10-31 |
| 00850003069630 | OC-2200 | TOPCON HEALTHCARE INC | 2025-10-31 |
| 00850003069647 | OC-2200 | TOPCON HEALTHCARE INC | 2025-10-31 |
| 00850003069722 | OC-2200 | TOPCON HEALTHCARE INC | 2025-10-31 |
| 00850003069715 | OC-2200 | TOPCON HEALTHCARE INC | 2025-10-31 |
| 00850003069708 | OC-2200 | TOPCON HEALTHCARE INC | 2025-10-31 |
| 00850003069692 | OC-2200 | TOPCON HEALTHCARE INC | 2025-10-31 |
| 00850003069685 | OC-2200 | TOPCON HEALTHCARE INC | 2025-10-31 |
| 00850003069678 | OC-2200 | TOPCON HEALTHCARE INC | 2025-10-31 |
| 00850003069661 | OC-2200 | TOPCON HEALTHCARE INC | 2025-10-31 |
| 00850053428852 | OC-2200 | TOPCON HEALTHCARE INC | 2025-10-23 |