Chair, Surgical, Ac-Powered
FDA product code GBB · Class I (low risk) · 21 CFR 878.4960 · General, Plastic Surgery
8510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K964102 | Tenet Tibial Fracture SupportGBB · Traditional | Tenet Medical Engineering | 12/05/1996SE |
| K893598 | Hydraulic Foot Operated StoolGBB · Traditional | Arthro-Medic, Inc. | 10/10/1989SE |
| K831385 | Lithotomy Chair #415GBB · Traditional | Midmark Corp. | 06/02/1983SE |
| K831325 | NutromatGBB · Traditional | Medlog GmbH Marketing Services | 06/02/1983SE |
| K822264 | Nagashima SN Operator's ChairGBB · Traditional | Kelleher Corp. | 10/13/1982SE |
| K822251 | Examination & Treatment ChairsGBB · Traditional | Kelleher Corp. | 08/27/1982SE |
| K822013 | Nagashima SN Automatic Treatment ChairGBB · Traditional | Kelleher Corp. | 07/28/1982SE |
| K820636 | Storz #6500 Power Examination ChairGBB · Traditional | Storz Instrument Co. | 03/26/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0996-2015 Class II | Powered stretcher chair used during facial and eye surgeries. One chair per package.The firm is finding that the stretcher chair controllers are moving the chairs involuntarily. | TransMotion Medical Inc | 11/14/2014Terminated |