ENTRAX TRACTION UNIT
Device Facts
| Record ID | K780763 |
|---|---|
| Device Name | ENTRAX TRACTION UNIT |
| Applicant | Orthopedic Equipment Co., Inc. |
| Product Code | HSR · Orthopedic |
| Decision Date | May 16, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.5890 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A noninvasive traction component is a device, such as a head halter, pelvic belt, or a traction splint, that does not penetrate the skin and is intended to assist in connecting a patient to a traction apparatus so that a therapeutic pulling force may be applied to the patient's body.
