21 CFR 888.5890 — Splint, Traction
Orthopedic (OR) · Part 888 Subpart E—Surgical Devices · § 888.5890
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HSP | Splint, Traction | 1 | 1 | |
| HSQ | Belt, Pelvic, Traction | 1 | 1 | |
| HSR | Unit, Traction, Hip, Non-Powered, Non-Penetrating | 1 | 1 | |
| HSS | Halter, Head, Traction | 1 | 3 | |
| KQZ | Component, Traction, Non-Invasive | 1 | 11 |
