IQK
27 FDA 510(k) clearances · Product code
29 daysmedian time to decision
121 days90th percentile
27clearances measured
FDA profile
- Official device name
- Orthosis, Cervical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3490
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1997: 3 · 2002: 4 · 2014: 7 · 2016: 20 · 2017: 11 · 2018: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DORMIE NECK SUPPORT SYSTEM (K930730) | The Western Diagnostics Co. | 1993-07-22 |
| SCHUL-TEC IMMOBILIZER (K926291) | Medical Emergency Support Equipment | 1993-03-30 |
| NOVA PILLOW (K895477) | Nova Health Systems, Inc. | 1990-01-10 |
| MEDICAL DISPOSABLE BEDDING (K896042) | Keystone Veterinary Supplies, Inc. | 1990-01-10 |
| BATTLE CREEK PILLOW (K882264) | Battle Creek Equipment Co. | 1988-08-09 |
| CERVICAL COLLARS & HEAD HALTERS (K850465) | Abco Dealers, Inc. | 1985-04-25 |
| STIFNICK IMMOBILIZING COLLAR (K832990) | Laerdal California, Inc. | 1983-11-07 |
| HEAD-IMMOBILIZER (K832001) | Int'L Safety Corp. | 1983-07-12 |
| VARI-SUPPORT NECK POSTURE PILLOW (K831582) | Body Therapeutics, Inc. | 1983-06-15 |
| CERVICAL PILLOW (K830350) | Deip Enterprises, Inc. | 1983-03-09 |
| VINYL EXTRICATION COLLAR (K830348) | Deip Enterprises, Inc. | 1983-03-09 |
| DISPOSABLE EXTRICATION COLLAR (K830351) | Deip Enterprises, Inc. | 1983-03-09 |
| CERVICAL COLLAR (K823667) | Warm & Form, Orthopedic Materials | 1982-12-30 |
| U-WAY QUICKOLLAR (K823247) | Ems Industries, Inc. | 1982-11-16 |
| CERVICAL COLLAR (K823161) | Warm & Form, Orthopedic Materials | 1982-11-10 |
| VARI-SUPPORT NECK POSTURE PILLOW (K821837) | Body Therapeutics, Inc. | 1982-07-20 |
| BECSIC COLLAR (K820366) | Blackstone & Breglio Industries | 1982-03-01 |
| LOXLEY EMERGENCY CERVICAL COLLAR (K812019) | Loxley Medical | 1981-10-02 |
| EXECUTIVE COLLAR (K811298) | Orthomedics | 1981-05-27 |
| BONNER BRACE (K810024) | Bee Ent. | 1981-01-23 |
| CONPHAR ADJUSTABLE CERVICAL COLLAR (K803147) | Conphar, Inc. | 1981-01-08 |
| LOW BACK POSTURE PILLOW (K802442) | Body Therapeutics, Inc. | 1980-10-31 |
| RESTRAINT, PROTECTIVE (K801628) | The Owenby Co. | 1980-08-07 |
| BASHAW CERVICAL IMMOBILIZER DEVICE (K800108) | Bashaw Custom Specialties, Inc. | 1980-02-29 |
| CERVICAL COLLAR (K780994) | Fox Instruments, Inc. | 1978-06-30 |
| COLLAR, CERVICAL, SPLIT (K780136) | Richard'S Medical Equip., Inc. | 1978-01-31 |
| NECKSAVER (K760644) | Health Saver Corp. | 1977-02-16 |
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Every clearance here is in the API, with alerts when new ones post.