IRS · Head Halter, Traction
Physical Medicine · 21 CFR 890.5925 · Class 1
Overview
| Product Code | IRS |
|---|---|
| Device Name | Head Halter, Traction |
| Regulation | 21 CFR 890.5925 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
A traction accessory is a nonpowered accessory device intended for medical purposes to be used with powered traction equipment to aid in exerting therapeutic pulling forces on the patient's body. This generic type of device includes the pulley, strap, head halter, and pelvic belt.
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 § 890.9. 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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K770724 | TRACTION DEVICES, INTERMITTENT, TX | Chattanooga Pharmacal Co. | Jul 11, 1977 | SESE |
Top Applicants
- Chattanooga Pharmacal Co. — 1 clearance
