HME · Chair, Ophthalmic, Ac-Powered
Ophthalmic · 21 CFR 886.1140 · Class 1
Overview
| Product Code | HME |
|---|---|
| Device Name | Chair, Ophthalmic, Ac-Powered |
| Regulation | 21 CFR 886.1140 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
An ophthalmic chair is an AC-powered or manual device with adjustable positioning in which a patient is to sit or recline during ophthalmological examination or treatment.
Classification Rationale
Class I. The AC-powered device and the manual device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The manual device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K930449 | MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR | Marco Ophthalmic, Inc. | Jul 6, 1993 | SESE |
| K914416 | BREATH-EASY, MODIFICATION | Icor AB | Jun 23, 1992 | SESE |
| K894018 | RELIANCE(R) 6200 EXAMINATION CHAIR | Reliance Medical Products, Inc. | Sep 12, 1989 | SESE |
| K870112 | STORZ ENT/OPHTHALMIC MAXI CHAIR | Storz Instrument Co. | Feb 12, 1987 | SESE |
| K864574 | MAC 150E OPTHALMIC CHAIR | Koken Mfg Company, Inc. | Dec 15, 1986 | SESE |
| K864494 | MODEL 6500 OPTHALMIC CHAIR | Koken Mfg Company, Inc. | Dec 15, 1986 | SESE |
| K863728 | THE ERGOSYSTEM CHAIR | Charles D. Bell, Inc. | Oct 31, 1986 | SESE |
| K863008 | -OM WEST 2000 GNATUS CHAIR | Sds Dental, Inc. | Sep 24, 1986 | SESE |
| K853743 | TECHNA VISION, INC. ELECTRIC CHAIR | Techna Vision | Oct 17, 1985 | SESE |
| K853151 | RELIANCE 5000 | F. & F. Koenigkramer | Sep 5, 1985 | SESE |
| K853150 | RELIANCE 6100 | F. & F. Koenigkramer | Sep 5, 1985 | SESE |
| K853149 | RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 | F. & F. Koenigkramer | Sep 5, 1985 | SESE |
| K842045 | WOODLYN CLASSIC EXAM. CHAIR | Woodlyn, Inc. | Jun 19, 1984 | SESE |
| K833539 | DOWING OPHTHALMIC CHAIR AC-POWERED | Vision Health Technology | Mar 5, 1984 | SESE |
| K801638 | A O CUSTOM II CHAIR AND STAND | American Optical Corp. | Aug 13, 1980 | SESE |
| K781801 | MAXI-CHAIR | Surgical Mechanical Research, Inc. | Nov 3, 1978 | SESE |
Top Applicants
- F. & F. Koenigkramer — 3 clearances
- Koken Mfg Company, Inc. — 2 clearances
- American Optical Corp. — 1 clearance
- Charles D. Bell, Inc. — 1 clearance
- Icor AB — 1 clearance
