FZK · Chair, Surgical, Non-Electrical
General, Plastic Surgery · 21 CFR 878.4950 · Class 1
Overview
| Product Code | FZK |
|---|---|
| Device Name | Chair, Surgical, Non-Electrical |
| Regulation | 21 CFR 878.4950 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
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.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K962528 | OLYMPUS MOBILE CHAIR/COUCH | Keymed (Medical & Industrial Equipment), Ltd. | Dec 12, 1996 | SESE |
| K842030 | NEUTRAL POS-CHAIR SURGEON CHAIR | Neutral Pos-Chair Co. | Jul 23, 1984 | SESE |
Top Applicants
- Neutral Pos-Chair Co. — 1 clearance
- Keymed (Medical & Industrial Equipment), Ltd. — 1 clearance
