GBB · Chair, Surgical, Ac-Powered
General, Plastic Surgery · 21 CFR 878.4960 · Class 1
Overview
| Product Code | GBB |
|---|---|
| Device Name | Chair, Surgical, Ac-Powered |
| Regulation | 21 CFR 878.4960 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K964102 | TENET TIBIAL FRACTURE SUPPORT | Tenet Medical Engineering | Dec 5, 1996 | SESE |
| K893598 | HYDRAULIC FOOT OPERATED STOOL | Arthro-Medic, Inc. | Oct 10, 1989 | SESE |
| K831385 | LITHOTOMY CHAIR #415 | Midmark Corp. | Jun 2, 1983 | SESE |
| K831325 | NUTROMAT | Medlog GmbH Marketing Services | Jun 2, 1983 | SESE |
| K822264 | NAGASHIMA SN OPERATOR'S CHAIR | Kelleher Corp. | Oct 13, 1982 | SESE |
| K822251 | EXAMINATION & TREATMENT CHAIRS | Kelleher Corp. | Aug 27, 1982 | SESE |
| K822013 | NAGASHIMA SN AUTOMATIC TREATMENT CHAIR | Kelleher Corp. | Jul 28, 1982 | SESE |
| K820636 | STORZ #6500 POWER EXAMINATION CHAIR | Storz Instrument Co. | Mar 26, 1982 | SESE |
Top Applicants
- Kelleher Corp. — 3 clearances
- Arthro-Medic, Inc. — 1 clearance
- Medlog GmbH Marketing Services — 1 clearance
- Midmark Corp. — 1 clearance
- Storz Instrument Co. — 1 clearance
