U-WAY QUICKOLLAR

Orthosis, Cervical

EMS INDUSTRIES, INC.

The following data is part of a premarket notification filed by Ems Industries, Inc. with the FDA for U-way Quickollar.

Pre-market Notification Details

Device IDK823247
510k NumberK823247
Device Name:U-WAY QUICKOLLAR
ClassificationOrthosis, Cervical
Applicant EMS INDUSTRIES, INC. 803 N. Front St. Suite 3 McHenry,  IL  60050
Product CodeIQK  
CFR Regulation Number890.3490 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-11-01
Decision Date1982-11-16

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