LHX · Trousers, Anti-Shock
Cardiovascular · 21 CFR 870.5800 · Class 2
Overview
| Product Code | LHX |
|---|---|
| Device Name | Trousers, Anti-Shock |
| Regulation | 21 CFR 870.5800 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K953763 | GLADIATOR ANTISHOCK PANTS | Jobst Institute, Inc. | Nov 28, 1995 | SESE |
| K874774 | TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERS | Vinyl Technology, Inc. | Feb 8, 1988 | SESE |
| K841605 | BP TRAUMA AIR PANTS | Bp Medical Systems, Inc. | Jul 6, 1984 | SESE |
| K812564 | ZEE LIFE SUPPORT AIR PANTS | Zee Medical Products Co., Inc. | Oct 23, 1981 | SESE |
Top Applicants
- Bp Medical Systems, Inc. — 1 clearance
- Jobst Institute, Inc. — 1 clearance
- Vinyl Technology, Inc. — 1 clearance
- Zee Medical Products Co., Inc. — 1 clearance