HSS · Halter, Head, Traction
Orthopedic · 21 CFR 888.5890 · Class 1
Overview
| Product Code | HSS |
|---|---|
| Device Name | Halter, Head, Traction |
| Regulation | 21 CFR 888.5890 |
| Device Class | Class 1 |
| Review Panel | Orthopedic |
| GMP Exempt | Yes |
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.
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K771109 | ORTHOPEDIC SOFT GOODS | Orthopedic Systems, Inc. | Jun 27, 1977 | SESE |
| K770910 | MEDISHIELD CERVICAL COLLAR | Fraser Sweatman, Inc. | May 25, 1977 | SESE |
| K760869 | SPLIT CERVICAL COLLAR/HEAD HALTER | Orthopedic Equipment Co., Inc. | Nov 1, 1976 | SESE |
Top Applicants
- Orthopedic Systems, Inc. — 1 clearance
- Orthopedic Equipment Co., Inc. — 1 clearance
- Fraser Sweatman, Inc. — 1 clearance
