← Product Code [HSR](/submissions/OR/subpart-e%E2%80%94surgical-devices/HSR) · K780763

# ENTRAX TRACTION UNIT (K780763)

_Orthopedic Equipment Co., Inc. · HSR · May 16, 1978 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HSR/K780763

## Device Facts

- **Applicant:** Orthopedic Equipment Co., Inc.
- **Product Code:** [HSR](/submissions/OR/subpart-e%E2%80%94surgical-devices/HSR.md)
- **Decision Date:** May 16, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.5890
- **Device Class:** Class 1
- **Review Panel:** Orthopedic

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HSR/K780763](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HSR/K780763)

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