Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4950](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4950) → FZK — Chair, Surgical, Non-Electrical

# FZK · Chair, Surgical, Non-Electrical

_General, Plastic Surgery · 21 CFR 878.4950 · Class 1_

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

## Overview

- **Product Code:** FZK
- **Device Name:** Chair, Surgical, Non-Electrical
- **Regulation:** [21 CFR 878.4950](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4950)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

## 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 the limitations in § 878.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K962528](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZK/K962528.md) | OLYMPUS MOBILE CHAIR/COUCH | Keymed (Medical & Industrial Equipment), Ltd. | Dec 12, 1996 | SESE |
| [K842030](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZK/K842030.md) | NEUTRAL POS-CHAIR SURGEON CHAIR | Neutral Pos-Chair Co. | Jul 23, 1984 | SESE |

## Top Applicants

- Keymed (Medical & Industrial Equipment), Ltd. — 1 clearance
- Neutral Pos-Chair Co. — 1 clearance

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

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