Chair, Ophthalmic, Ac-Powered
FDA product code HME · Class I (low risk) · 21 CFR 886.1140 · Ophthalmic
16510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K930449 | Marco, Marcotilt, Encore and Custom ChairHME · Traditional | Marco Ophthalmic, Inc. | 07/06/1993SE |
| K914416 | Breath-Easy, ModificationHME · Traditional | Icor AB | 06/23/1992SE |
| K894018 | Reliance(R) 6200 Examination ChairHME · Traditional | Reliance Medical Products, Inc. | 09/12/1989SE |
| K870112 | Storz Ent/Ophthalmic Maxi ChairHME · Traditional | Storz Instrument Co. | 02/12/1987SE |
| K864574 | Mac 150E Opthalmic ChairHME · Traditional | Koken Mfg Company, Inc. | 12/15/1986SE |
| K864494 | Model 6500 Opthalmic ChairHME · Traditional | Koken Mfg Company, Inc. | 12/15/1986SE |
| K863728 | The Ergosystem ChairHME · Traditional | Charles D. Bell, Inc. | 10/31/1986SE |
| K863008 | -Om West 2000 Gnatus ChairHME · Traditional | Sds Dental, Inc. | 09/24/1986SE |
| K853743 | Techna Vision, Inc. Electric ChairHME · Traditional | Techna Vision | 10/17/1985SE |
| K853151 | Reliance 5000HME · Traditional | F. & F. Koenigkramer | 09/05/1985SE |
| K853150 | Reliance 6100HME · Traditional | F. & F. Koenigkramer | 09/05/1985SE |
| K853149 | Reliance 1000, Reliance 1500, Reliance 2000HME · Traditional | F. & F. Koenigkramer | 09/05/1985SE |
| K842045 | Woodlyn Classic Exam. ChairHME · Traditional | Woodlyn, Inc. | 06/19/1984SE |
| K833539 | Dowing Ophthalmic Chair Ac-PoweredHME · Traditional | Vision Health Technology | 03/05/1984SE |
| K801638 | A O Custom II Chair and StandHME · Traditional | American Optical Corp. | 08/13/1980SE |
| K781801 | Maxi-ChairHME · Traditional | Surgical Mechanical Research, Inc. | 11/03/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2212-2023 Class II | UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient…Service life of the electrical seat part drive of the treatment chair may be shortened unexpectedly after… | UFSK - International OSYS Gmbh | 05/31/2023Open, Classified |