EPW · Support, Head, Surgical, Ent
General, Plastic Surgery · 21 CFR 878.4950 · Class 1
Overview
| Product Code | EPW |
|---|---|
| Device Name | Support, Head, Surgical, Ent |
| 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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K821306 | HEAD-UP SUPINE SAFETY SUPPORT CUSHION | Med-Life, Inc. | Jun 7, 1982 | SESE |
| K801326 | ANSPACH OPERATING TABLE SUPPORT/SPINAL | The Anspach Effort, Inc. | Jun 26, 1980 | SESE |
Top Applicants
- Med-Life, Inc. — 1 clearance
- The Anspach Effort, Inc. — 1 clearance
