DIGIKIT NONPNEUMATIC TOURNIQUET
Device Facts
| Record ID | K860095 |
|---|---|
| Device Name | DIGIKIT NONPNEUMATIC TOURNIQUET |
| Applicant | Orthofab, Inc. |
| Product Code | KCY · General, Plastic Surgery |
| Decision Date | Jan 24, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.5910 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.
