PPS · Sleeve, Head And Neck, Compressible
Cardiovascular · 21 CFR 870.5800 · Class 2
Overview
| Product Code | PPS |
|---|---|
| Device Name | Sleeve, Head And Neck, Compressible |
| Regulation | 21 CFR 870.5800 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K153311 | Flexitouch System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | Sep 14, 2016 | SESE |
Top Applicants
- Tactile Systems Technology, Inc. (Dba Tactile Medical) — 1 clearance
