KQZ · Component, Traction, Non-Invasive
Orthopedic · 21 CFR 888.5890 · Class 1
Overview
| Product Code | KQZ |
|---|---|
| Device Name | Component, Traction, Non-Invasive |
| 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 (11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K884132 | TECNOL BUCKS TRACTION W/HEEL PROTECTOR | Technol, Inc. | Oct 11, 1988 | SESE |
| K882640 | TECNOL SECURE-ALL PELVIC TRACTION BELT | Tecnol New Jersey Wound Care, Inc. | Jul 27, 1988 | SESE |
| K871900 | OVER DRAPE LEG HOLDER | Avec Scientific Design Corp. | Jun 16, 1987 | SESE |
| K871296 | T.E.D.(TM) TRACTION DEVICE | The Kendal Co. | Apr 15, 1987 | SESE |
| K854270 | MURPHY ADJUSTABLE SPLINT | Comfortex, Inc. | Dec 9, 1985 | SESE |
| K831002 | TPG 1000 | Physical Diagnostics, Inc. | Jun 24, 1983 | SESE |
| K823660 | UNIVERSAL BUCKS TRACTION | Warm & Form, Orthopedic Materials | Dec 30, 1982 | SESE |
| K823163 | UNIVERSAL BUCKS TRACTION | Warm & Form, Orthopedic Materials | Nov 10, 1982 | SESE |
| K821252 | HOFFMAN UNIVERSAL FOOT SUPPORT | Howmedica Corp. | Jun 22, 1982 | SESE |
| K802869 | BACKTRAC 90-90 TRACTION | Backtrac | Dec 11, 1980 | SESE |
| K781754 | SPLINT, HOAKE INFLATABLE AIR | Depuy, Inc. | Nov 8, 1978 | SESE |
Top Applicants
- Warm & Form, Orthopedic Materials — 2 clearances
- The Kendal Co. — 1 clearance
- Tecnol New Jersey Wound Care, Inc. — 1 clearance
- Technol, Inc. — 1 clearance
- Physical Diagnostics, Inc. — 1 clearance
