Product code IQK
- Device name
- Orthosis, Cervical
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.3490
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K930730 | DORMIE NECK SUPPORT SYSTEM | The Western Diagnostics Co. | 1993-07-22 |
| K926291 | SCHUL-TEC IMMOBILIZER | Medical Emergency Support Equipment | 1993-03-30 |
| K895477 | NOVA PILLOW | Nova Health Systems, Inc. | 1990-01-10 |
| K896042 | MEDICAL DISPOSABLE BEDDING | Keystone Veterinary Supplies, Inc. | 1990-01-10 |
| K882264 | BATTLE CREEK PILLOW | Battle Creek Equipment Co. | 1988-08-09 |
| K850465 | CERVICAL COLLARS & HEAD HALTERS | Abco Dealers, Inc. | 1985-04-25 |
| K832990 | STIFNICK IMMOBILIZING COLLAR | Laerdal California, Inc. | 1983-11-07 |
| K832001 | HEAD-IMMOBILIZER | Int'L Safety Corp. | 1983-07-12 |
| K831582 | VARI-SUPPORT NECK POSTURE PILLOW | Body Therapeutics, Inc. | 1983-06-15 |
| K830348 | VINYL EXTRICATION COLLAR | Deip Enterprises, Inc. | 1983-03-09 |
| K830350 | CERVICAL PILLOW | Deip Enterprises, Inc. | 1983-03-09 |
| K830351 | DISPOSABLE EXTRICATION COLLAR | Deip Enterprises, Inc. | 1983-03-09 |
| K823667 | CERVICAL COLLAR | Warm & Form, Orthopedic Materials | 1982-12-30 |
| K823247 | U-WAY QUICKOLLAR | Ems Industries, Inc. | 1982-11-16 |
| K823161 | CERVICAL COLLAR | Warm & Form, Orthopedic Materials | 1982-11-10 |
| K821837 | VARI-SUPPORT NECK POSTURE PILLOW | Body Therapeutics, Inc. | 1982-07-20 |
| K820366 | BECSIC COLLAR | Blackstone & Breglio Industries | 1982-03-01 |
| K812019 | LOXLEY EMERGENCY CERVICAL COLLAR | Loxley Medical | 1981-10-02 |
| K811298 | EXECUTIVE COLLAR | Orthomedics | 1981-05-27 |
| K810024 | BONNER BRACE | Bee Ent. | 1981-01-23 |
| K803147 | CONPHAR ADJUSTABLE CERVICAL COLLAR | Conphar, Inc. | 1981-01-08 |
| K802442 | LOW BACK POSTURE PILLOW | Body Therapeutics, Inc. | 1980-10-31 |
| K801628 | RESTRAINT, PROTECTIVE | The Owenby Co. | 1980-08-07 |
| K800108 | BASHAW CERVICAL IMMOBILIZER DEVICE | Bashaw Custom Specialties, Inc. | 1980-02-29 |
| K780994 | CERVICAL COLLAR | Fox Instruments, Inc. | 1978-06-30 |
| K780136 | COLLAR, CERVICAL, SPLIT | Richard'S Medical Equip., Inc. | 1978-01-31 |
| K760644 | NECKSAVER | Health Saver Corp. | 1977-02-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00057475611019 | BIOS Living | Thermor Ltd | 2024-05-23 |
| 05707480024629 | Ambu® Perfit Collar™ | Ambu A/S | 2023-02-09 |
| 05707480120062 | curaplex® | Ambu A/S | 2022-12-09 |
| 05707480107506 | Ambu® Redi-ACE | Ambu A/S | 2022-12-09 |
| 05707480024650 | Ambu® Mini Perfit ACE™ | Ambu A/S | 2022-12-08 |
| 05707480120055 | curaplex® | Ambu A/S | 2022-12-08 |
| 05707480107490 | Ambu® Redi-ACE | Ambu A/S | 2022-12-08 |
| 05707480038619 | Ambu® Immobilization Kit, with | Ambu A/S | 2022-12-08 |
| 05707480037315 | Ambu® Immobilization Kit, with | Ambu A/S | 2022-12-08 |
| 05707480024667 | Ambu® Immobilization Kit, with | Ambu A/S | 2022-12-08 |
| 05707480024643 | Ambu® Military Perfit ACE™ | Ambu A/S | 2022-12-08 |
| 05707480024636 | Ambu® Perfit ACE™ | Ambu A/S | 2022-12-08 |
| 05707480024612 | Ambu® Perfit Collar™ | Ambu A/S | 2022-12-08 |
| 05707480024599 | Ambu® Perfit Collar™ | Ambu A/S | 2022-12-08 |
| 05707480024674 | Ambu® Immobilization Kit, with | Ambu A/S | 2022-12-08 |
| 05707480024513 | Ambu® Perfit Collar™ | Ambu A/S | 2022-12-08 |
| 05707480024520 | Ambu® Perfit Collar™ | Ambu A/S | 2022-12-08 |
| 05707480024537 | Ambu® Perfit Collar™ | Ambu A/S | 2022-12-08 |
| 05707480024544 | Ambu® Perfit Collar™ | Ambu A/S | 2022-12-08 |
| 05707480024551 | Ambu® Perfit Collar™ | Ambu A/S | 2022-12-08 |
| 05707480024568 | Ambu® Perfit Collar™ | Ambu A/S | 2022-12-08 |
| 05707480024575 | Ambu® Perfit Collar™ | Ambu A/S | 2022-12-08 |
| 05707480024582 | Ambu® Perfit Collar™ | Ambu A/S | 2022-12-08 |
| 05707480024605 | Ambu® Perfit Collar™ | Ambu A/S | 2022-12-08 |
| 00616784435626 | Cervical Collar | Dynarex Corporation | 2020-11-18 |
| 00616784435725 | Cervical Collar | Dynarex Corporation | 2020-11-18 |
| 00616784435824 | Cervical Collar | Dynarex Corporation | 2020-11-18 |
| 00616784435923 | Cervical Collar | Dynarex Corporation | 2020-11-18 |
| 50050428585257 | DRIVEMEDICAL | Drive Devilbiss Healthcare | 2019-06-21 |
| 00612479231429 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2018-11-09 |