FDA-Device2022-02-16Class II

R82 by ETAC Push Brace for High-Low

R82 A/S
Hazard

The chrome surface of the push brace can crack during use, potentially cutting the user.

Sold states
Worldwide distribution - US Nationwide distribution in the states of North Carolina and California and the countries of Czech Republic, Finland, Germany, Greece, Holland, Italy, Japan, Norway, Poland, Russia, Sweden, and United Kingdom.
Affected count
396 units
Manufactured in
Parallelvej 3, N/A, Gedved, N/A, Denmark
Products
R82 by ETAC Push Brace for High-Low

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0569-2022

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