JEA · Table, Surgical With Orthopedic Accessories, Ac-Powered
General, Plastic Surgery · 21 CFR 878.4960 · Class 1
Overview
| Product Code | JEA |
|---|---|
| Device Name | Table, Surgical With Orthopedic Accessories, 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 (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K953071 | STRYKER COMMAND2 OFFICE CONSOLE | Stryker Instruments | Aug 8, 1995 | SESE |
| K924094 | MEND APC | Mend Technologies, Inc. | Mar 30, 1993 | SESE |
| K910736 | JACKSON MULTIPURPOSE OPERATING TABLE | Orthopedic Systems, Inc. | May 21, 1991 | SESE |
| K911522 | ARTHROBOT(TM) WRIST HOLDER ACCESSORY | Andronic Devices, Ltd. | Apr 29, 1991 | SESE |
| K900290 | SKYTRON MODEL 1100 AND MODEL 142 | Skytron, Div. the Kmw Group, Inc. | Feb 20, 1990 | SESE |
| K894789 | DMI 250 SERIES POWER SURGERY TABLE | M.D. Intl., Inc. | Aug 29, 1989 | SESE |
| K881060 | OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION) | Orthopedic Systems, Inc. | Mar 25, 1988 | SESE |
| K874762 | ARTHROTRACT UPPER LIMB TRACTION ACCESSORY | Andronic Devices, Ltd. | Dec 10, 1987 | SESE |
| K873080 | ARTHROBOT 101 UPPER LIMB TRACTION ACCESSORY | Andronic Devices, Ltd. | Nov 25, 1987 | SESE |
| K873079 | ARTHROBOT 100 UPPER LIMB POSITIONER | Andronic Devices, Ltd. | Nov 25, 1987 | SESE |
Top Applicants
- Andronic Devices, Ltd. — 4 clearances
- Orthopedic Systems, Inc. — 2 clearances
- M.D. Intl., Inc. — 1 clearance
- Mend Technologies, Inc. — 1 clearance
- Skytron, Div. the Kmw Group, Inc. — 1 clearance
