CCX · Support, Patient Position
Anesthesiology · 21 CFR 868.6820 · Class 1
Overview
| Product Code | CCX |
|---|---|
| Device Name | Support, Patient Position |
| Regulation | 21 CFR 868.6820 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A patient position support is a device intended to maintain the position of an anesthetized patient during surgery.
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 § 868.9.
Cleared Devices (8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K943837 | CHIN UP | Edward Carden | Oct 14, 1994 | SESE |
| K932305 | VILA-COOKE(TM) ANESTHESIA PILLOW | Sharn, Inc. | Oct 5, 1993 | SESE |
| K934235 | SNIFF POSITION PILLOW | American Medical Development, Inc. | Oct 1, 1993 | SESE |
| K861915 | SURGICAL HEAD SUPPORT | Treace Medical, Inc. | May 30, 1986 | SESE |
| K833022 | AIR UTERINE DISPLACER-AUD 120 | Scientific Sales Intl., Inc. | Oct 14, 1983 | SESE |
| K821838 | VARI-SUPPORT LOW BACK POSTURE PILLOW | Body Therapeutics, Inc. | Jul 20, 1982 | SESE |
| K810035 | PRENATAL SUPPORT PILLOW | Supportech, Inc. | Jan 23, 1981 | SESE |
| K801330 | ANSPACH LEG SUPPORT | The Anspach Effort, Inc. | Jun 26, 1980 | SESE |
Top Applicants
- Treace Medical, Inc. — 1 clearance
- The Anspach Effort, Inc. — 1 clearance
- Supportech, Inc. — 1 clearance
- Sharn, Inc. — 1 clearance
- Scientific Sales Intl., Inc. — 1 clearance
