510(k) K823247
- Device
- U-WAY QUICKOLLAR
- Applicant
- EMS INDUSTRIES, INC.
- 510(k) number
- K823247
- Product code
- IQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-11-16
- Date received
- 1982-11-01
- Regulation
- 890.3490
- Classification name
- Orthosis, Cervical
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3033790380
- 1641302
- 3015429713
- 3006227741
- 3014847663
- 3020978037
- 2182979
- 3015526491
- 3007853907
- 9680284
- 3016678950
- 2182345
- 3016707060
- 3007942528
- 3015727296
- 3008114965
- 1511629
- 1043591
- 3005906953
- 3003924186
- 3006266055
- 3039396083
- 3011657181
- 3014377018
- 3030522263
- 3005037196
- 3016426850
- 3006085220
- 3010123014
- 3015142701
- 3016591678
- 3010515776
- 3003887292
- 3009273990
- 3010987649
- 3013657868
- 3007207474
- 3008146511
- 2031918
- 3036779619
- 3009131011
- 3021313801
- 3006750986
- 3027500264
- 1043214
- 3010371670
- 3004713344
- 3008114969
- 3008466086
- 3014658541
- 1422443
- 3014982318
- 3010239526
- 1016498
- 9680411
- 3008048783
- 3030630899
- 3031583032
- 1812798
- 1063727
- 3011556461
- 3012363901
- 3012281713
- 3010785927
- 1026765
- 3042251620
- 3003890514
- 3013770567
- 3023158731
- 3012316249
- 8030607
- 3042227943
- 3033796310
- 3018503755
- 9680668
- 3045857302
- 3007222552
- 9681385
- 3011689956
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IQK #
| 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 |
| K823161 | CERVICAL COLLAR | Warm & Form, Orthopedic Materials | 1982-11-10 |
| K821837 | VARI-SUPPORT NECK POSTURE PILLOW | Body Therapeutics, Inc. | 1982-07-20 |
Legacy Summary#
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FDA Review#
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