LGX · Table, Examination, Medical, Powered
General, Plastic Surgery · 21 CFR 878.4960 · Class 1
Overview
| Product Code | LGX |
|---|---|
| Device Name | Table, Examination, Medical, 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 (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K945163 | ECHOCARDIOGRAPHY | Tri W-G, Inc. | Feb 17, 1995 | SESE |
| K894144 | POWER EXAMINATION TABLE MODEL # 405 | Midmark Corp. | Aug 28, 1989 | SESE |
| K894134 | POWER EXAMINATION TABLE MODEL # 411 | Midmark Corp. | Aug 28, 1989 | SESE |
| K883680 | MEDALIST EXAMINATION TABLE | Hamilton Industries, Inc. | Oct 4, 1988 | SESE |
| K882010 | POWER EXAMINATION TABLE | Enochs Mfg., Inc. | Jul 13, 1988 | SESE |
| K864072 | ADEC 1005-C CHAIR | Cherne Industries, Inc. | Nov 7, 1986 | SESE |
| K860519 | RELIANCE MODEL 200 PODIATRY CHAIR | F. & F. Koenigkramer | Feb 19, 1986 | SESE |
| K845023 | STORZ PLASTIC SURGERY & EXAMINATION LOUNGE 7000 | Storz Instrument Co. | Jan 28, 1985 | SESE |
| K830294 | MEDICAL EXAM TABLE | Coe Laboratories, Inc. | Jan 11, 1984 | SESE |
| K832768 | S & W SW52E W/POWER BACK LIFT | S & W Enterprises, Inc. | Sep 20, 1983 | SESE |
| K820823 | MULTIPLE, MODEL #17 | Midmark Corp. | Apr 21, 1982 | SESE |
| K811623 | SMR PARAGON CHAIR TABLE | Smr | Jul 2, 1981 | SESE |
| K811190 | THREE MODELS OF TABLES, STOOLS, & LIGHTS | Midmark Corp. | May 8, 1981 | SESE |
| K810900 | CASTLE PROCEDURE AND RITTER EXAM. TABLES | Sybron Corp. | Apr 21, 1981 | SESE |
Top Applicants
- Midmark Corp. — 4 clearances
- Cherne Industries, Inc. — 1 clearance
- Coe Laboratories, Inc. — 1 clearance
- Enochs Mfg., Inc. — 1 clearance
- F. & F. Koenigkramer — 1 clearance
