IQK · Orthosis, Cervical
Physical Medicine · 21 CFR 890.3490 · Class 1
Overview
| Product Code | IQK |
|---|---|
| Device Name | Orthosis, Cervical |
| Regulation | 21 CFR 890.3490 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.
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 (20 of 27)
Showing 20 most recent of 27 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K930730 | DORMIE NECK SUPPORT SYSTEM | The Western Diagnostics Co. | Jul 22, 1993 | SESE |
| K926291 | SCHUL-TEC IMMOBILIZER | Medical Emergency Support Equipment | Mar 30, 1993 | SESE |
| K896042 | MEDICAL DISPOSABLE BEDDING | Keystone Veterinary Supplies, Inc. | Jan 10, 1990 | SESE |
| K895477 | NOVA PILLOW | Nova Health Systems, Inc. | Jan 10, 1990 | SESE |
| K882264 | BATTLE CREEK PILLOW | Battle Creek Equipment Co. | Aug 9, 1988 | SESE |
| K850465 | CERVICAL COLLARS & HEAD HALTERS | Abco Dealers, Inc. | Apr 25, 1985 | SESE |
| K832990 | STIFNICK IMMOBILIZING COLLAR | Laerdal California, Inc. | Nov 7, 1983 | SESE |
| K832001 | HEAD-IMMOBILIZER | Int'L Safety Corp. | Jul 12, 1983 | SESE |
| K831582 | VARI-SUPPORT NECK POSTURE PILLOW | Body Therapeutics, Inc. | Jun 15, 1983 | SESE |
| K830351 | DISPOSABLE EXTRICATION COLLAR | Deip Enterprises, Inc. | Mar 9, 1983 | SESE |
| K830350 | CERVICAL PILLOW | Deip Enterprises, Inc. | Mar 9, 1983 | SESE |
| K830348 | VINYL EXTRICATION COLLAR | Deip Enterprises, Inc. | Mar 9, 1983 | SESE |
| K823667 | CERVICAL COLLAR | Warm & Form, Orthopedic Materials | Dec 30, 1982 | SESE |
| K823247 | U-WAY QUICKOLLAR | Ems Industries, Inc. | Nov 16, 1982 | SESE |
| K823161 | CERVICAL COLLAR | Warm & Form, Orthopedic Materials | Nov 10, 1982 | SESE |
| K821837 | VARI-SUPPORT NECK POSTURE PILLOW | Body Therapeutics, Inc. | Jul 20, 1982 | SESE |
| K820366 | BECSIC COLLAR | Blackstone & Breglio Industries | Mar 1, 1982 | SESE |
| K812019 | LOXLEY EMERGENCY CERVICAL COLLAR | Loxley Medical | Oct 2, 1981 | SESE |
| K811298 | EXECUTIVE COLLAR | Orthomedics | May 27, 1981 | SESE |
| K810024 | BONNER BRACE | Bee Ent. | Jan 23, 1981 | SESE |
Top Applicants
- Body Therapeutics, Inc. — 3 clearances
- Deip Enterprises, Inc. — 3 clearances
- Warm & Form, Orthopedic Materials — 2 clearances
- Abco Dealers, Inc. — 1 clearance
- Bashaw Custom Specialties, Inc. — 1 clearance
