Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4960](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4960) → JEA — Table, Surgical With Orthopedic Accessories, Ac-Powered

# JEA · Table, Surgical With Orthopedic Accessories, Ac-Powered

_General, Plastic Surgery · 21 CFR 878.4960 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEA

## Overview

- **Product Code:** JEA
- **Device Name:** Table, Surgical With Orthopedic Accessories, Ac-Powered
- **Regulation:** [21 CFR 878.4960](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4960)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEA/K953071.md) | STRYKER COMMAND2 OFFICE CONSOLE | Stryker Instruments | Aug 8, 1995 | SESE |
| [K924094](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEA/K924094.md) | MEND APC | Mend Technologies, Inc. | Mar 30, 1993 | SESE |
| [K910736](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEA/K910736.md) | JACKSON MULTIPURPOSE OPERATING TABLE | Orthopedic Systems, Inc. | May 21, 1991 | SESE |
| [K911522](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEA/K911522.md) | ARTHROBOT(TM) WRIST HOLDER ACCESSORY | Andronic Devices, Ltd. | Apr 29, 1991 | SESE |
| [K900290](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEA/K900290.md) | SKYTRON MODEL 1100 AND MODEL 142 | Skytron, Div. the Kmw Group, Inc. | Feb 20, 1990 | SESE |
| [K894789](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEA/K894789.md) | DMI 250 SERIES POWER SURGERY TABLE | M.D. Intl., Inc. | Aug 29, 1989 | SESE |
| [K881060](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEA/K881060.md) | OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION) | Orthopedic Systems, Inc. | Mar 25, 1988 | SESE |
| [K874762](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEA/K874762.md) | ARTHROTRACT UPPER LIMB TRACTION ACCESSORY | Andronic Devices, Ltd. | Dec 10, 1987 | SESE |
| [K873080](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEA/K873080.md) | ARTHROBOT 101 UPPER LIMB TRACTION ACCESSORY | Andronic Devices, Ltd. | Nov 25, 1987 | SESE |
| [K873079](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEA/K873079.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEA](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JEA)

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