21 CFR 870.5800 — Sleeve, Limb, Compressible
Cardiovascular (CV) · Part 870 Subpart F—Cardiovascular Therapeutic Devices · § 870.5800
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | 2 | 350 | 3rd Party |
| LHX | Trousers, Anti-Shock | 2 | 4 | |
| PPS | Sleeve, Head And Neck, Compressible | 2 | 1 | 3rd Party |
