ILZ · Accessories, Traction
Physical Medicine · 21 CFR 890.5925 · Class 1
Overview
| Product Code | ILZ |
|---|---|
| Device Name | Accessories, 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 (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K921711 | FLEXION DISTRATION SUPPORT | Altoona Medical Supply | Jul 13, 1992 | SESE |
| K895382 | VIBRA-TRAC TRACTION TABLE | Vibra-Trac Industries | Oct 16, 1989 | SESE |
| K884340 | AMX-110, AMX-II AND AMX-III | Dyna-Med | Jan 24, 1989 | SESE |
| K852398 | VECTOR BAR SUSPENSION/TRACTION UNIT | Powlan Manufacturing Co. | Aug 12, 1985 | SESE |
| K844490 | TRACTION ACCESSORIES | Jerome Medical | Feb 21, 1985 | SESE |
| K831135 | SAUNDERS #7080 CERVICAL TRACTION SYS | Chattanooga Group, Inc. | Jun 24, 1983 | SESE |
| K830245 | HEAD HALTER | Warm & Form, Orthopedic Materials | Mar 9, 1983 | SESE |
| K823659 | PELVIC TRACTION BELT | Warm & Form, Orthopedic Materials | Dec 30, 1982 | SESE |
| K823166 | PELVIC TRACTION BELT | Warm & Form, Orthopedic Materials | Nov 10, 1982 | SESE |
| K820663 | BOGER AUTO-TRACTION DEVICE | D.C. Medical Device, Inc. | May 3, 1982 | SESE |
| K791808 | CERVI-TRAC | Dr. K.G. Rude | Oct 1, 1979 | SESE |
| K780227 | BANDAGE SPREADER BLOCK | Biomet, Inc. | Mar 15, 1978 | SESE |
| K780234 | TRACTION BELT, PELVIC | Biomet, Inc. | Feb 23, 1978 | SESE |
| K780226 | SPREADER BARS | Biomet, Inc. | Feb 17, 1978 | SESE |
| K770607 | TRACTION HARNESS | Will Ross Co. | Apr 8, 1977 | SESE |
Top Applicants
- Biomet, Inc. — 3 clearances
- Warm & Form, Orthopedic Materials — 3 clearances
- Altoona Medical Supply — 1 clearance
- Chattanooga Group, Inc. — 1 clearance
- D.C. Medical Device, Inc. — 1 clearance
