The following data is part of a premarket notification filed by Ems Industries, Inc. with the FDA for U-way Quickollar.
Device ID | K823247 |
510k Number | K823247 |
Device Name: | U-WAY QUICKOLLAR |
Classification | Orthosis, Cervical |
Applicant | EMS INDUSTRIES, INC. 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | IQK |
CFR Regulation Number | 890.3490 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-11-01 |
Decision Date | 1982-11-16 |